Ignite Creation Date:
2025-12-24 @ 6:50 PM
Ignite Modification Date:
2026-01-02 @ 4:15 AM
Study NCT ID:
NCT03938857
Status:
TERMINATED
Last Update Posted:
2021-11-05
First Post:
2019-04-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
DOSE Trial of Opioid Sparing Effect
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016638', 'term': 'Critical Illness'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005283', 'term': 'Fentanyl'}, {'id': 'D020927', 'term': 'Dexmedetomidine'}], 'ancestors': [{'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mara.becker@duke.edu', 'phone': '919-613-1942', 'title': 'Mara L. Becker, MD, MSCE', 'organization': 'Duke University'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 28 days or until discharge from the ICU (whichever is first)', 'description': 'No participants were enrolled in the Fen. SOC+Dex.(.5mcg/kg + .75mcg/kg/hr) group.', 'eventGroups': [{'id': 'EG000', 'title': 'Fen. SOC+Saline Placebo (Bolus+Infusion)', 'description': 'Fentanyl standard of care (SOC) titrated to sedation + saline placebo (bolus + infusion)\n\nFentanyl: Fentanyl standard of care', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 4, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Fen. SOC+Dex.(.5mcg/kg + .25mcg/kg/hr)', 'description': 'Fentanyl SOC titrated to sedation + Dexmedetomidine (0.5mcg/kg bolus load + 0.2mcg/kg/hr infusion)\n\nFentanyl: Fentanyl standard of care\n\nDexmedetomidine: Dexmedetomidine (0.5 mcg/kg + 0.2 mcg/kg/hr)', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 9, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': 'Fen. SOC+Dex.(.5mcg/kg + .5mcg/kg/hr)', 'description': 'Fentanyl SOC titrated to sedation + Dexmedetomidine (0.5mcg/kg bolus load + 0.5mcg/kg/hr infusion)\n\nFentanyl: Fentanyl standard of care\n\nDexmedetomidine: Dexmedetomidine (0.5 mcg/kg + 0.5 mcg/kg/hr)', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 8, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG003', 'title': 'Fen. SOC+Dex.(.5mcg/kg + .75mcg/kg/hr)', 'description': 'Fentanyl SOC titrated to sedation + Dexmedetomidine (0.5mcg/kg bolus load + 0.7mcg/kg/hr infusion)\n\nFentanyl: Fentanyl standard of care\n\nDexmedetomidine: Dexmedetomidine (0.5 mcg/kg + 0.7 mcg/kg/hr)', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Anaesthetic and allied procedural complications', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA High Level'}, {'term': 'Anxiety symptoms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA High Level'}, {'term': 'Bladder and urethral symptoms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA High Level'}, {'term': 'Colitis (excl infective)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA High Level'}, {'term': 'Conditions associated with abnormal gas exchange', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA High Level'}, {'term': 'Encephalopathies NEC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA High Level'}, {'term': 'Febrile disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA High Level'}, {'term': 'General signs and symptoms NEC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA High Level'}, {'term': 'Heart rate and pulse investigations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA High Level'}, {'term': 'Hepatic failure and associated disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA High Level'}, {'term': 'Laryngeal spasm, oedema and obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA High Level'}, {'term': 'Magnesium metabolism disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA High Level'}, {'term': 'Nausea and vomiting symptoms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA High Level'}, {'term': 'Parainfluenzae viral infections', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA High Level'}, {'term': 'Pneumothorax and pleural effusions NEC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA High Level'}, {'term': 'Protein metabolism disorders NEC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA High Level'}, {'term': 'Rate and rhythm disorders NEC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA High Level'}, {'term': 'Renal failure and impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA High Level'}, {'term': 'Respiratory tract and thoracic cavity procedural complications', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA High Level'}, {'term': 'Seizures and seizure disorders NEC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA High Level'}, {'term': 'Stereotypies and automatisms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA High Level'}, {'term': 'Tremor (excl congenital)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA High Level'}, {'term': 'Vascular hypotensive disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA High Level'}], 'seriousEvents': [{'term': 'General signs and symptoms NEC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA High Level'}, {'term': 'Colitis (excl infective)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA High Level'}, {'term': 'Seizures and seizure disorder NEC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA High Level'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Daily Dose of Fentanyl in mcg/kg/hr (Micrograms Per Kilogram Per Hour)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Fen. SOC+Saline Placebo (Bolus+Infusion)', 'description': 'Fentanyl standard of care (SOC) titrated to sedation + saline placebo (bolus + infusion)\n\nFentanyl: Fentanyl standard of care'}, {'id': 'OG001', 'title': 'Fen. SOC+Dex.(.5mcg/kg + .25mcg/kg/hr)', 'description': 'Fentanyl SOC titrated to sedation + Dexmedetomidine (0.5mcg/kg bolus load + 0.2mcg/kg/hr infusion)\n\nFentanyl: Fentanyl standard of care\n\nDexmedetomidine: Dexmedetomidine (0.5 mcg/kg + 0.2 mcg/kg/hr)'}, {'id': 'OG002', 'title': 'Fen. SOC+Dex.(.5mcg/kg + .5mcg/kg/hr)', 'description': 'Fentanyl SOC titrated to sedation + Dexmedetomidine (0.5mcg/kg bolus load + 0.5mcg/kg/hr infusion)\n\nFentanyl: Fentanyl standard of care\n\nDexmedetomidine: Dexmedetomidine (0.5 mcg/kg + 0.5 mcg/kg/hr)'}, {'id': 'OG003', 'title': 'Fen. SOC+Dex.(.5mcg/kg + .75mcg/kg/hr)', 'description': 'Fentanyl SOC titrated to sedation + Dexmedetomidine (0.5mcg/kg bolus load + 0.7mcg/kg/hr infusion)\n\nFentanyl: Fentanyl standard of care\n\nDexmedetomidine: Dexmedetomidine (0.5 mcg/kg + 0.7 mcg/kg/hr)'}], 'classes': [{'categories': [{'measurements': [{'value': '2.25', 'spread': '2.15', 'groupId': 'OG000'}, {'value': '2.68', 'spread': '1.53', 'groupId': 'OG001'}, {'value': '3.23', 'spread': '3.30', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.814', 'groupIds': ['OG000', 'OG001', 'OG002'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.1088295', 'ciLowerLimit': '-1.035508', 'ciUpperLimit': '0.8178494', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.4728041', 'estimateComment': 'Estimated value represents interaction between treatment and days.', 'groupDescription': 'Placebo group compared to combined Dexmedetomidine groups.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'through day 7 of mechanical ventilation or initial extubation (whichever is first)', 'description': 'Characterize the opioid-sparing effect of dexmedetomidine when co-administered with fentanyl in children receiving mechanical ventilation. Characterization of differences between dosing exposures for the four groups will allow estimation of the opioid-sparing effect of dexmedetomidine.', 'unitOfMeasure': 'mcg/kg/hr', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients who did not have fentanyl reported were excluded. No participants were enrolled in the Fen. SOC+Dex.(.5mcg/kg + .75mcg/kg/hr) group.'}, {'type': 'SECONDARY', 'title': 'Sedation Based on the State Behavior Scale (SBS) Relative to Fentanyl Plasma Concentrations (Cmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Fen. SOC+Saline Placebo (Bolus+Infusion)', 'description': 'Fentanyl standard of care (SOC) titrated to sedation + saline placebo (bolus + infusion)\n\nFentanyl: Fentanyl standard of care'}, {'id': 'OG001', 'title': 'Fen. SOC+Dex.(.5mcg/kg + .25mcg/kg/hr)', 'description': 'Fentanyl SOC titrated to sedation + Dexmedetomidine (0.5mcg/kg bolus load + 0.2mcg/kg/hr infusion)\n\nFentanyl: Fentanyl standard of care\n\nDexmedetomidine: Dexmedetomidine (0.5 mcg/kg + 0.2 mcg/kg/hr)'}, {'id': 'OG002', 'title': 'Fen. SOC+Dex.(.5mcg/kg + .5mcg/kg/hr)', 'description': 'Fentanyl SOC titrated to sedation + Dexmedetomidine (0.5mcg/kg bolus load + 0.5mcg/kg/hr infusion)\n\nFentanyl: Fentanyl standard of care\n\nDexmedetomidine: Dexmedetomidine (0.5 mcg/kg + 0.5 mcg/kg/hr)'}, {'id': 'OG003', 'title': 'Fen. SOC+Dex.(.5mcg/kg + .75mcg/kg/hr)', 'description': 'Fentanyl SOC titrated to sedation + Dexmedetomidine (0.5mcg/kg bolus load + 0.7mcg/kg/hr infusion)\n\nFentanyl: Fentanyl standard of care\n\nDexmedetomidine: Dexmedetomidine (0.5 mcg/kg + 0.7 mcg/kg/hr)'}], 'timeFrame': 'through day 7 of mechanical ventilation or initial extubation (whichever is first)', 'description': 'Characterize the exposure response relationships of fentanyl and dexmedetomidine when administered alone or in combination in children receiving mechanical ventilation. PK is known to be altered in children compared to adults, and in those with critical illness. Characterization of pharmacokinetic-pharmacodynamic relationships can improve dose optimization when dose may not be equivalent to plasma exposure and related effect. The SBS is a 6-point scale that ranges from +2 to -3 with -3. Scores that are more negative reflect a more sedated state (-3). Scores that are more positive reflect a more agitated state (+2). Zero is awake and easily calmed.', 'reportingStatus': 'POSTED', 'populationDescription': 'Data not collected. The study was terminated early due to enrollment challenges.'}, {'type': 'SECONDARY', 'title': 'Sedation Based on SBS Scale Relative to Fentanyl Plasma Concentrations (Cmin)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Fen. SOC+Saline Placebo (Bolus+Infusion)', 'description': 'Fentanyl standard of care (SOC) titrated to sedation + saline placebo (bolus + infusion)\n\nFentanyl: Fentanyl standard of care'}, {'id': 'OG001', 'title': 'Fen. SOC+Dex.(.5mcg/kg + .25mcg/kg/hr)', 'description': 'Fentanyl SOC titrated to sedation + Dexmedetomidine (0.5mcg/kg bolus load + 0.2mcg/kg/hr infusion)\n\nFentanyl: Fentanyl standard of care\n\nDexmedetomidine: Dexmedetomidine (0.5 mcg/kg + 0.2 mcg/kg/hr)'}, {'id': 'OG002', 'title': 'Fen. SOC+Dex.(.5mcg/kg + .5mcg/kg/hr)', 'description': 'Fentanyl SOC titrated to sedation + Dexmedetomidine (0.5mcg/kg bolus load + 0.5mcg/kg/hr infusion)\n\nFentanyl: Fentanyl standard of care\n\nDexmedetomidine: Dexmedetomidine (0.5 mcg/kg + 0.5 mcg/kg/hr)'}, {'id': 'OG003', 'title': 'Fen. SOC+Dex.(.5mcg/kg + .75mcg/kg/hr)', 'description': 'Fentanyl SOC titrated to sedation + Dexmedetomidine (0.5mcg/kg bolus load + 0.7mcg/kg/hr infusion)\n\nFentanyl: Fentanyl standard of care\n\nDexmedetomidine: Dexmedetomidine (0.5 mcg/kg + 0.7 mcg/kg/hr)'}], 'timeFrame': 'through day 7 of mechanical ventilation or initial extubation (whichever is first)', 'description': 'Characterize the exposure response relationships of fentanyl and dexmedetomidine when administered alone or in combination in children receiving mechanical ventilation. PK is known to be altered in children compared to adults, and in those with critical illness. Characterization of pharmacokinetic-pharmacodynamic relationships can improve dose optimization when dose may not be equivalent to plasma exposure and related effect. The SBS is a 6-point scale that ranges from +2 to -3 with -3. Scores that are more negative reflect a more sedated state (-3). Scores that are more positive reflect a more agitated state (+2). Zero is awake and easily calmed.', 'reportingStatus': 'POSTED', 'populationDescription': 'Data not collected. The study was terminated early due to enrollment challenges.'}, {'type': 'SECONDARY', 'title': 'Sedation Based on SBS Scale Relative to Fentanyl Plasma Concentrations (Css)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Fen. SOC+Saline Placebo (Bolus+Infusion)', 'description': 'Fentanyl standard of care (SOC) titrated to sedation + saline placebo (bolus + infusion)\n\nFentanyl: Fentanyl standard of care'}, {'id': 'OG001', 'title': 'Fen. SOC+Dex.(.5mcg/kg + .25mcg/kg/hr)', 'description': 'Fentanyl SOC titrated to sedation + Dexmedetomidine (0.5mcg/kg bolus load + 0.2mcg/kg/hr infusion)\n\nFentanyl: Fentanyl standard of care\n\nDexmedetomidine: Dexmedetomidine (0.5 mcg/kg + 0.2 mcg/kg/hr)'}, {'id': 'OG002', 'title': 'Fen. SOC+Dex.(.5mcg/kg + .5mcg/kg/hr)', 'description': 'Fentanyl SOC titrated to sedation + Dexmedetomidine (0.5mcg/kg bolus load + 0.5mcg/kg/hr infusion)\n\nFentanyl: Fentanyl standard of care\n\nDexmedetomidine: Dexmedetomidine (0.5 mcg/kg + 0.5 mcg/kg/hr)'}, {'id': 'OG003', 'title': 'Fen. SOC+Dex.(.5mcg/kg + .75mcg/kg/hr)', 'description': 'Fentanyl SOC titrated to sedation + Dexmedetomidine (0.5mcg/kg bolus load + 0.7mcg/kg/hr infusion)\n\nFentanyl: Fentanyl standard of care\n\nDexmedetomidine: Dexmedetomidine (0.5 mcg/kg + 0.7 mcg/kg/hr)'}], 'timeFrame': 'through day 7 of mechanical ventilation or initial extubation (whichever is first)', 'description': 'Characterize the exposure response relationships of fentanyl and dexmedetomidine when administered alone or in combination in children receiving mechanical ventilation. PK is known to be altered in children compared to adults, and in those with critical illness. Characterization of pharmacokinetic-pharmacodynamic relationships can improve dose optimization when dose may not be equivalent to plasma exposure and related effect. The SBS is a 6-point scale that ranges from +2 to -3 with -3. Scores that are more negative reflect a more sedated state (-3). Scores that are more positive reflect a more agitated state (+2). Zero is awake and easily calmed.', 'reportingStatus': 'POSTED', 'populationDescription': 'Data not collected. The study was terminated early due to enrollment challenges.'}, {'type': 'SECONDARY', 'title': 'Sedation Based on SBS Scale Relative to Fentanyl Plasma Concentrations (AUC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Fen. SOC+Saline Placebo (Bolus+Infusion)', 'description': 'Fentanyl standard of care (SOC) titrated to sedation + saline placebo (bolus + infusion)\n\nFentanyl: Fentanyl standard of care'}, {'id': 'OG001', 'title': 'Fen. SOC+Dex.(.5mcg/kg + .25mcg/kg/hr)', 'description': 'Fentanyl SOC titrated to sedation + Dexmedetomidine (0.5mcg/kg bolus load + 0.2mcg/kg/hr infusion)\n\nFentanyl: Fentanyl standard of care\n\nDexmedetomidine: Dexmedetomidine (0.5 mcg/kg + 0.2 mcg/kg/hr)'}, {'id': 'OG002', 'title': 'Fen. SOC+Dex.(.5mcg/kg + .5mcg/kg/hr)', 'description': 'Fentanyl SOC titrated to sedation + Dexmedetomidine (0.5mcg/kg bolus load + 0.5mcg/kg/hr infusion)\n\nFentanyl: Fentanyl standard of care\n\nDexmedetomidine: Dexmedetomidine (0.5 mcg/kg + 0.5 mcg/kg/hr)'}, {'id': 'OG003', 'title': 'Fen. SOC+Dex.(.5mcg/kg + .75mcg/kg/hr)', 'description': 'Fentanyl SOC titrated to sedation + Dexmedetomidine (0.5mcg/kg bolus load + 0.7mcg/kg/hr infusion)\n\nFentanyl: Fentanyl standard of care\n\nDexmedetomidine: Dexmedetomidine (0.5 mcg/kg + 0.7 mcg/kg/hr)'}], 'timeFrame': 'through day 7 of mechanical ventilation or initial extubation (whichever is first)', 'description': 'Characterize the exposure response relationships of fentanyl and dexmedetomidine when administered alone or in combination in children receiving mechanical ventilation. PK is known to be altered in children compared to adults, and in those with critical illness. Characterization of pharmacokinetic-pharmacodynamic relationships can improve dose optimization when dose may not be equivalent to plasma exposure and related effect. The SBS is a 6-point scale that ranges from +2 to -3 with -3. Scores that are more negative reflect a more sedated state (-3). Scores that are more positive reflect a more agitated state (+2). Zero is awake and easily calmed.', 'reportingStatus': 'POSTED', 'populationDescription': 'Data not collected. The study was terminated early due to enrollment challenges.'}, {'type': 'SECONDARY', 'title': 'Sedation Based on SBS Scale Relative to Dexmedetomidine Plasma Concentrations (Cmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Fen. SOC+Saline Placebo (Bolus+Infusion)', 'description': 'Fentanyl standard of care (SOC) titrated to sedation + saline placebo (bolus + infusion)\n\nFentanyl: Fentanyl standard of care'}, {'id': 'OG001', 'title': 'Fen. SOC+Dex.(.5mcg/kg + .25mcg/kg/hr)', 'description': 'Fentanyl SOC titrated to sedation + Dexmedetomidine (0.5mcg/kg bolus load + 0.2mcg/kg/hr infusion)\n\nFentanyl: Fentanyl standard of care\n\nDexmedetomidine: Dexmedetomidine (0.5 mcg/kg + 0.2 mcg/kg/hr)'}, {'id': 'OG002', 'title': 'Fen. SOC+Dex.(.5mcg/kg + .5mcg/kg/hr)', 'description': 'Fentanyl SOC titrated to sedation + Dexmedetomidine (0.5mcg/kg bolus load + 0.5mcg/kg/hr infusion)\n\nFentanyl: Fentanyl standard of care\n\nDexmedetomidine: Dexmedetomidine (0.5 mcg/kg + 0.5 mcg/kg/hr)'}, {'id': 'OG003', 'title': 'Fen. SOC+Dex.(.5mcg/kg + .75mcg/kg/hr)', 'description': 'Fentanyl SOC titrated to sedation + Dexmedetomidine (0.5mcg/kg bolus load + 0.7mcg/kg/hr infusion)\n\nFentanyl: Fentanyl standard of care\n\nDexmedetomidine: Dexmedetomidine (0.5 mcg/kg + 0.7 mcg/kg/hr)'}], 'timeFrame': 'through day 7 of mechanical ventilation or initial extubation (whichever is first)', 'description': 'Characterize the exposure response relationships of fentanyl and dexmedetomidine when administered alone or in combination in children receiving mechanical ventilation. PK is known to be altered in children compared to adults, and in those with critical illness. Characterization of pharmacokinetic-pharmacodynamic relationships can improve dose optimization when dose may not be equivalent to plasma exposure and related effect. The SBS is a 6-point scale that ranges from +2 to -3 with -3. Scores that are more negative reflect a more sedated state (-3). Scores that are more positive reflect a more agitated state (+2). Zero is awake and easily calmed.', 'reportingStatus': 'POSTED', 'populationDescription': 'Data not collected. The study was terminated early due to enrollment challenges.'}, {'type': 'SECONDARY', 'title': 'Sedation Based on SBS Scale Relative to Dexmedetomidine Plasma Concentrations (Cmin)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Fen. SOC+Saline Placebo (Bolus+Infusion)', 'description': 'Fentanyl standard of care (SOC) titrated to sedation + saline placebo (bolus + infusion)\n\nFentanyl: Fentanyl standard of care'}, {'id': 'OG001', 'title': 'Fen. SOC+Dex.(.5mcg/kg + .25mcg/kg/hr)', 'description': 'Fentanyl SOC titrated to sedation + Dexmedetomidine (0.5mcg/kg bolus load + 0.2mcg/kg/hr infusion)\n\nFentanyl: Fentanyl standard of care\n\nDexmedetomidine: Dexmedetomidine (0.5 mcg/kg + 0.2 mcg/kg/hr)'}, {'id': 'OG002', 'title': 'Fen. SOC+Dex.(.5mcg/kg + .5mcg/kg/hr)', 'description': 'Fentanyl SOC titrated to sedation + Dexmedetomidine (0.5mcg/kg bolus load + 0.5mcg/kg/hr infusion)\n\nFentanyl: Fentanyl standard of care\n\nDexmedetomidine: Dexmedetomidine (0.5 mcg/kg + 0.5 mcg/kg/hr)'}, {'id': 'OG003', 'title': 'Fen. SOC+Dex.(.5mcg/kg + .75mcg/kg/hr)', 'description': 'Fentanyl SOC titrated to sedation + Dexmedetomidine (0.5mcg/kg bolus load + 0.7mcg/kg/hr infusion)\n\nFentanyl: Fentanyl standard of care\n\nDexmedetomidine: Dexmedetomidine (0.5 mcg/kg + 0.7 mcg/kg/hr)'}], 'timeFrame': 'through day 7 of mechanical ventilation or initial extubation (whichever is first)', 'description': 'Characterize the exposure response relationships of fentanyl and dexmedetomidine when administered alone or in combination in children receiving mechanical ventilation. PK is known to be altered in children compared to adults, and in those with critical illness. Characterization of pharmacokinetic-pharmacodynamic relationships can improve dose optimization when dose may not be equivalent to plasma exposure and related effect. The SBS is a 6-point scale that ranges from +2 to -3 with -3. Scores that are more negative reflect a more sedated state (-3). Scores that are more positive reflect a more agitated state (+2). Zero is awake and easily calmed.', 'reportingStatus': 'POSTED', 'populationDescription': 'Data not collected. The study was terminated early due to enrollment challenges.'}, {'type': 'SECONDARY', 'title': 'Sedation Based on SBS Scale Relative to Dexmedetomidine Plasma Concentrations (Css)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Fen. SOC+Saline Placebo (Bolus+Infusion)', 'description': 'Fentanyl standard of care (SOC) titrated to sedation + saline placebo (bolus + infusion)\n\nFentanyl: Fentanyl standard of care'}, {'id': 'OG001', 'title': 'Fen. SOC+Dex.(.5mcg/kg + .25mcg/kg/hr)', 'description': 'Fentanyl SOC titrated to sedation + Dexmedetomidine (0.5mcg/kg bolus load + 0.2mcg/kg/hr infusion)\n\nFentanyl: Fentanyl standard of care\n\nDexmedetomidine: Dexmedetomidine (0.5 mcg/kg + 0.2 mcg/kg/hr)'}, {'id': 'OG002', 'title': 'Fen. SOC+Dex.(.5mcg/kg + .5mcg/kg/hr)', 'description': 'Fentanyl SOC titrated to sedation + Dexmedetomidine (0.5mcg/kg bolus load + 0.5mcg/kg/hr infusion)\n\nFentanyl: Fentanyl standard of care\n\nDexmedetomidine: Dexmedetomidine (0.5 mcg/kg + 0.5 mcg/kg/hr)'}, {'id': 'OG003', 'title': 'Fen. SOC+Dex.(.5mcg/kg + .75mcg/kg/hr)', 'description': 'Fentanyl SOC titrated to sedation + Dexmedetomidine (0.5mcg/kg bolus load + 0.7mcg/kg/hr infusion)\n\nFentanyl: Fentanyl standard of care\n\nDexmedetomidine: Dexmedetomidine (0.5 mcg/kg + 0.7 mcg/kg/hr)'}], 'timeFrame': 'through day 7 of mechanical ventilation or initial extubation (whichever is first)', 'description': 'Characterize the exposure response relationships of fentanyl and dexmedetomidine when administered alone or in combination in children receiving mechanical ventilation. PK is known to be altered in children compared to adults, and in those with critical illness. Characterization of pharmacokinetic-pharmacodynamic relationships can improve dose optimization when dose may not be equivalent to plasma exposure and related effect. The SBS is a 6-point scale that ranges from +2 to -3 with -3. Scores that are more negative reflect a more sedated state (-3). Scores that are more positive reflect a more agitated state (+2). Zero is awake and easily calmed.', 'reportingStatus': 'POSTED', 'populationDescription': 'Data not collected. The study was terminated early due to enrollment challenges.'}, {'type': 'SECONDARY', 'title': 'Sedation Based on SBS Scale Relative to Dexmedetomidine Plasma Concentrations (AUC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Fen. SOC+Saline Placebo (Bolus+Infusion)', 'description': 'Fentanyl standard of care (SOC) titrated to sedation + saline placebo (bolus + infusion)\n\nFentanyl: Fentanyl standard of care'}, {'id': 'OG001', 'title': 'Fen. SOC+Dex.(.5mcg/kg + .25mcg/kg/hr)', 'description': 'Fentanyl SOC titrated to sedation + Dexmedetomidine (0.5mcg/kg bolus load + 0.2mcg/kg/hr infusion)\n\nFentanyl: Fentanyl standard of care\n\nDexmedetomidine: Dexmedetomidine (0.5 mcg/kg + 0.2 mcg/kg/hr)'}, {'id': 'OG002', 'title': 'Fen. SOC+Dex.(.5mcg/kg + .5mcg/kg/hr)', 'description': 'Fentanyl SOC titrated to sedation + Dexmedetomidine (0.5mcg/kg bolus load + 0.5mcg/kg/hr infusion)\n\nFentanyl: Fentanyl standard of care\n\nDexmedetomidine: Dexmedetomidine (0.5 mcg/kg + 0.5 mcg/kg/hr)'}, {'id': 'OG003', 'title': 'Fen. SOC+Dex.(.5mcg/kg + .75mcg/kg/hr)', 'description': 'Fentanyl SOC titrated to sedation + Dexmedetomidine (0.5mcg/kg bolus load + 0.7mcg/kg/hr infusion)\n\nFentanyl: Fentanyl standard of care\n\nDexmedetomidine: Dexmedetomidine (0.5 mcg/kg + 0.7 mcg/kg/hr)'}], 'timeFrame': 'through day 7 of mechanical ventilation or initial extubation (whichever is first)', 'description': 'Characterize the exposure response relationships of fentanyl and dexmedetomidine when administered alone or in combination in children receiving mechanical ventilation. PK is known to be altered in children compared to adults, and in those with critical illness. Characterization of pharmacokinetic-pharmacodynamic relationships can improve dose optimization when dose may not be equivalent to plasma exposure and related effect. The SBS is a 6-point scale that ranges from +2 to -3 with -3. Scores that are more negative reflect a more sedated state (-3). Scores that are more positive reflect a more agitated state (+2). Zero is awake and easily calmed.', 'reportingStatus': 'POSTED', 'populationDescription': 'Data not collected. The study was terminated early due to enrollment challenges.'}, {'type': 'SECONDARY', 'title': 'Sedation Based on Richmond Agitation and Sedation Scale (RASS) Scale Relative to Fentanyl Plasma Concentrations (Cmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Fen. SOC+Saline Placebo (Bolus+Infusion)', 'description': 'Fentanyl standard of care (SOC) titrated to sedation + saline placebo (bolus + infusion)\n\nFentanyl: Fentanyl standard of care'}, {'id': 'OG001', 'title': 'Fen. SOC+Dex.(.5mcg/kg + .25mcg/kg/hr)', 'description': 'Fentanyl SOC titrated to sedation + Dexmedetomidine (0.5mcg/kg bolus load + 0.2mcg/kg/hr infusion)\n\nFentanyl: Fentanyl standard of care\n\nDexmedetomidine: Dexmedetomidine (0.5 mcg/kg + 0.2 mcg/kg/hr)'}, {'id': 'OG002', 'title': 'Fen. SOC+Dex.(.5mcg/kg + .5mcg/kg/hr)', 'description': 'Fentanyl SOC titrated to sedation + Dexmedetomidine (0.5mcg/kg bolus load + 0.5mcg/kg/hr infusion)\n\nFentanyl: Fentanyl standard of care\n\nDexmedetomidine: Dexmedetomidine (0.5 mcg/kg + 0.5 mcg/kg/hr)'}, {'id': 'OG003', 'title': 'Fen. SOC+Dex.(.5mcg/kg + .75mcg/kg/hr)', 'description': 'Fentanyl SOC titrated to sedation + Dexmedetomidine (0.5mcg/kg bolus load + 0.7mcg/kg/hr infusion)\n\nFentanyl: Fentanyl standard of care\n\nDexmedetomidine: Dexmedetomidine (0.5 mcg/kg + 0.7 mcg/kg/hr)'}], 'timeFrame': 'through day 7 of mechanical ventilation or initial extubation (whichever is first)', 'description': 'Characterize the exposure response relationships of fentanyl and dexmedetomidine when administered alone or in combination in children receiving mechanical ventilation. PK is known to be altered in children compared to adults, and in those with critical illness. Characterization of pharmacokinetic-pharmacodynamic relationships can improve dose optimization when dose may not be equivalent to plasma exposure and related effect. The RASS is a 10-point scale that ranges from -5 to +4 with -5=unarousable and +4=combative. Zero means the patient is alert and calm.', 'reportingStatus': 'POSTED', 'populationDescription': 'Data not collected. The study was terminated early due to enrollment challenges.'}, {'type': 'SECONDARY', 'title': 'Sedation Based on RASS Scale Relative to Fentanyl Plasma Concentrations (Cmin)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Fen. SOC+Saline Placebo (Bolus+Infusion)', 'description': 'Fentanyl standard of care (SOC) titrated to sedation + saline placebo (bolus + infusion)\n\nFentanyl: Fentanyl standard of care'}, {'id': 'OG001', 'title': 'Fen. SOC+Dex.(.5mcg/kg + .25mcg/kg/hr)', 'description': 'Fentanyl SOC titrated to sedation + Dexmedetomidine (0.5mcg/kg bolus load + 0.2mcg/kg/hr infusion)\n\nFentanyl: Fentanyl standard of care\n\nDexmedetomidine: Dexmedetomidine (0.5 mcg/kg + 0.2 mcg/kg/hr)'}, {'id': 'OG002', 'title': 'Fen. SOC+Dex.(.5mcg/kg + .5mcg/kg/hr)', 'description': 'Fentanyl SOC titrated to sedation + Dexmedetomidine (0.5mcg/kg bolus load + 0.5mcg/kg/hr infusion)\n\nFentanyl: Fentanyl standard of care\n\nDexmedetomidine: Dexmedetomidine (0.5 mcg/kg + 0.5 mcg/kg/hr)'}, {'id': 'OG003', 'title': 'Fen. SOC+Dex.(.5mcg/kg + .75mcg/kg/hr)', 'description': 'Fentanyl SOC titrated to sedation + Dexmedetomidine (0.5mcg/kg bolus load + 0.7mcg/kg/hr infusion)\n\nFentanyl: Fentanyl standard of care\n\nDexmedetomidine: Dexmedetomidine (0.5 mcg/kg + 0.7 mcg/kg/hr)'}], 'timeFrame': 'through day 7 of mechanical ventilation or initial extubation (whichever is first)', 'description': 'Characterize the exposure response relationships of fentanyl and dexmedetomidine when administered alone or in combination in children receiving mechanical ventilation. PK is known to be altered in children compared to adults, and in those with critical illness. Characterization of pharmacokinetic-pharmacodynamic relationships can improve dose optimization when dose may not be equivalent to plasma exposure and related effect. The RASS scale is a 10-pint scale that ranges from -5 to +4 with -5=unarousable and +4=combative. Zero means the patient is alert and calm.', 'reportingStatus': 'POSTED', 'populationDescription': 'Data not collected. The study was terminated early due to enrollment challenges.'}, {'type': 'SECONDARY', 'title': 'Sedation Based on RASS Scale Relative to Fentanyl Plasma Concentrations (Css)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Fen. SOC+Saline Placebo (Bolus+Infusion)', 'description': 'Fentanyl standard of care (SOC) titrated to sedation + saline placebo (bolus + infusion)\n\nFentanyl: Fentanyl standard of care'}, {'id': 'OG001', 'title': 'Fen. SOC+Dex.(.5mcg/kg + .25mcg/kg/hr)', 'description': 'Fentanyl SOC titrated to sedation + Dexmedetomidine (0.5mcg/kg bolus load + 0.2mcg/kg/hr infusion)\n\nFentanyl: Fentanyl standard of care\n\nDexmedetomidine: Dexmedetomidine (0.5 mcg/kg + 0.2 mcg/kg/hr)'}, {'id': 'OG002', 'title': 'Fen. SOC+Dex.(.5mcg/kg + .5mcg/kg/hr)', 'description': 'Fentanyl SOC titrated to sedation + Dexmedetomidine (0.5mcg/kg bolus load + 0.5mcg/kg/hr infusion)\n\nFentanyl: Fentanyl standard of care\n\nDexmedetomidine: Dexmedetomidine (0.5 mcg/kg + 0.5 mcg/kg/hr)'}, {'id': 'OG003', 'title': 'Fen. SOC+Dex.(.5mcg/kg + .75mcg/kg/hr)', 'description': 'Fentanyl SOC titrated to sedation + Dexmedetomidine (0.5mcg/kg bolus load + 0.7mcg/kg/hr infusion)\n\nFentanyl: Fentanyl standard of care\n\nDexmedetomidine: Dexmedetomidine (0.5 mcg/kg + 0.7 mcg/kg/hr)'}], 'timeFrame': 'through day 7 of mechanical ventilation or initial extubation (whichever is first)', 'description': 'Characterize the exposure response relationships of fentanyl and dexmedetomidine when administered alone or in combination in children receiving mechanical ventilation. PK is known to be altered in children compared to adults, and in those with critical illness. Characterization of pharmacokinetic-pharmacodynamic relationships can improve dose optimization when dose may not be equivalent to plasma exposure and related effect. The RASS scale is a 10-point scale that ranges from -5 to +4 with -5=unarousable and +4=combative. Zero means the patient is alert and calm.', 'reportingStatus': 'POSTED', 'populationDescription': 'Data not collected. The study was terminated early due to enrollment challenges.'}, {'type': 'SECONDARY', 'title': 'Sedation Based on RASS Scale Relative to Fentanyl Plasma Concentrations (AUC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Fen. SOC+Saline Placebo (Bolus+Infusion)', 'description': 'Fentanyl standard of care (SOC) titrated to sedation + saline placebo (bolus + infusion)\n\nFentanyl: Fentanyl standard of care'}, {'id': 'OG001', 'title': 'Fen. SOC+Dex.(.5mcg/kg + .25mcg/kg/hr)', 'description': 'Fentanyl SOC titrated to sedation + Dexmedetomidine (0.5mcg/kg bolus load + 0.2mcg/kg/hr infusion)\n\nFentanyl: Fentanyl standard of care\n\nDexmedetomidine: Dexmedetomidine (0.5 mcg/kg + 0.2 mcg/kg/hr)'}, {'id': 'OG002', 'title': 'Fen. SOC+Dex.(.5mcg/kg + .5mcg/kg/hr)', 'description': 'Fentanyl SOC titrated to sedation + Dexmedetomidine (0.5mcg/kg bolus load + 0.5mcg/kg/hr infusion)\n\nFentanyl: Fentanyl standard of care\n\nDexmedetomidine: Dexmedetomidine (0.5 mcg/kg + 0.5 mcg/kg/hr)'}, {'id': 'OG003', 'title': 'Fen. SOC+Dex.(.5mcg/kg + .75mcg/kg/hr)', 'description': 'Fentanyl SOC titrated to sedation + Dexmedetomidine (0.5mcg/kg bolus load + 0.7mcg/kg/hr infusion)\n\nFentanyl: Fentanyl standard of care\n\nDexmedetomidine: Dexmedetomidine (0.5 mcg/kg + 0.7 mcg/kg/hr)'}], 'timeFrame': 'through day 7 of mechanical ventilation or initial extubation (whichever is first)', 'description': 'Characterize the exposure response relationships of fentanyl and dexmedetomidine when administered alone or in combination in children receiving mechanical ventilation. PK is known to be altered in children compared to adults, and in those with critical illness. Characterization of pharmacokinetic-pharmacodynamic relationships can improve dose optimization when dose may not be equivalent to plasma exposure and related effect. The RASS scale is a 10-point scale that ranges from -5 to +4 with -5=unarousable and +4=combative. Zero means the patient is alert and calm.', 'reportingStatus': 'POSTED', 'populationDescription': 'Data not collected. The study was terminated early due to enrollment challenges.'}, {'type': 'SECONDARY', 'title': 'Sedation Based on RASS Scale Relative to Dexmedetomidine Plasma Concentrations (Cmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Fen. SOC+Saline Placebo (Bolus+Infusion)', 'description': 'Fentanyl standard of care (SOC) titrated to sedation + saline placebo (bolus + infusion)\n\nFentanyl: Fentanyl standard of care'}, {'id': 'OG001', 'title': 'Fen. SOC+Dex.(.5mcg/kg + .25mcg/kg/hr)', 'description': 'Fentanyl SOC titrated to sedation + Dexmedetomidine (0.5mcg/kg bolus load + 0.2mcg/kg/hr infusion)\n\nFentanyl: Fentanyl standard of care\n\nDexmedetomidine: Dexmedetomidine (0.5 mcg/kg + 0.2 mcg/kg/hr)'}, {'id': 'OG002', 'title': 'Fen. SOC+Dex.(.5mcg/kg + .5mcg/kg/hr)', 'description': 'Fentanyl SOC titrated to sedation + Dexmedetomidine (0.5mcg/kg bolus load + 0.5mcg/kg/hr infusion)\n\nFentanyl: Fentanyl standard of care\n\nDexmedetomidine: Dexmedetomidine (0.5 mcg/kg + 0.5 mcg/kg/hr)'}, {'id': 'OG003', 'title': 'Fen. SOC+Dex.(.5mcg/kg + .75mcg/kg/hr)', 'description': 'Fentanyl SOC titrated to sedation + Dexmedetomidine (0.5mcg/kg bolus load + 0.7mcg/kg/hr infusion)\n\nFentanyl: Fentanyl standard of care\n\nDexmedetomidine: Dexmedetomidine (0.5 mcg/kg + 0.7 mcg/kg/hr)'}], 'timeFrame': 'through day 7 of mechanical ventilation or initial extubation (whichever is first)', 'description': 'Characterize the exposure response relationships of fentanyl and dexmedetomidine when administered alone or in combination in children receiving mechanical ventilation. PK is known to be altered in children compared to adults, and in those with critical illness. Characterization of pharmacokinetic-pharmacodynamic relationships can improve dose optimization when dose may not be equivalent to plasma exposure and related effect. The RASS scale is a 10-point scale that ranges from -5 to +4 with -5=unarousable and +4=combative. Zero means the patient is alert and calm.', 'reportingStatus': 'POSTED', 'populationDescription': 'Data not collected. The study was terminated early due to enrollment challenges.'}, {'type': 'SECONDARY', 'title': 'Sedation Based on RASS Scale Relative to Dexmedetomidine Plasma Concentrations (Cmin)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Fen. SOC+Saline Placebo (Bolus+Infusion)', 'description': 'Fentanyl standard of care (SOC) titrated to sedation + saline placebo (bolus + infusion)\n\nFentanyl: Fentanyl standard of care'}, {'id': 'OG001', 'title': 'Fen. SOC+Dex.(.5mcg/kg + .25mcg/kg/hr)', 'description': 'Fentanyl SOC titrated to sedation + Dexmedetomidine (0.5mcg/kg bolus load + 0.2mcg/kg/hr infusion)\n\nFentanyl: Fentanyl standard of care\n\nDexmedetomidine: Dexmedetomidine (0.5 mcg/kg + 0.2 mcg/kg/hr)'}, {'id': 'OG002', 'title': 'Fen. SOC+Dex.(.5mcg/kg + .5mcg/kg/hr)', 'description': 'Fentanyl SOC titrated to sedation + Dexmedetomidine (0.5mcg/kg bolus load + 0.5mcg/kg/hr infusion)\n\nFentanyl: Fentanyl standard of care\n\nDexmedetomidine: Dexmedetomidine (0.5 mcg/kg + 0.5 mcg/kg/hr)'}, {'id': 'OG003', 'title': 'Fen. SOC+Dex.(.5mcg/kg + .75mcg/kg/hr)', 'description': 'Fentanyl SOC titrated to sedation + Dexmedetomidine (0.5mcg/kg bolus load + 0.7mcg/kg/hr infusion)\n\nFentanyl: Fentanyl standard of care\n\nDexmedetomidine: Dexmedetomidine (0.5 mcg/kg + 0.7 mcg/kg/hr)'}], 'timeFrame': 'through day 7 of mechanical ventilation or initial extubation (whichever is first)', 'description': 'Characterize the exposure response relationships of fentanyl and dexmedetomidine when administered alone or in combination in children receiving mechanical ventilation. PK is known to be altered in children compared to adults, and in those with critical illness. Characterization of pharmacokinetic-pharmacodynamic relationships can improve dose optimization when dose may not be equivalent to plasma exposure and related effect. The RASS scale is a 10-point scale that ranges from -5 to +4 with -5=unarousable and +4=combative. Zero means the patient is alert and calm.', 'reportingStatus': 'POSTED', 'populationDescription': 'Data not collected. The study was terminated early due to enrollment challenges.'}, {'type': 'SECONDARY', 'title': 'Sedation Based on RASS Scale Relative to Dexmedetomidine Plasma Concentrations (Css)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Fen. SOC+Saline Placebo (Bolus+Infusion)', 'description': 'Fentanyl standard of care (SOC) titrated to sedation + saline placebo (bolus + infusion)\n\nFentanyl: Fentanyl standard of care'}, {'id': 'OG001', 'title': 'Fen. SOC+Dex.(.5mcg/kg + .25mcg/kg/hr)', 'description': 'Fentanyl SOC titrated to sedation + Dexmedetomidine (0.5mcg/kg bolus load + 0.2mcg/kg/hr infusion)\n\nFentanyl: Fentanyl standard of care\n\nDexmedetomidine: Dexmedetomidine (0.5 mcg/kg + 0.2 mcg/kg/hr)'}, {'id': 'OG002', 'title': 'Fen. SOC+Dex.(.5mcg/kg + .5mcg/kg/hr)', 'description': 'Fentanyl SOC titrated to sedation + Dexmedetomidine (0.5mcg/kg bolus load + 0.5mcg/kg/hr infusion)\n\nFentanyl: Fentanyl standard of care\n\nDexmedetomidine: Dexmedetomidine (0.5 mcg/kg + 0.5 mcg/kg/hr)'}, {'id': 'OG003', 'title': 'Fen. SOC+Dex.(.5mcg/kg + .75mcg/kg/hr)', 'description': 'Fentanyl SOC titrated to sedation + Dexmedetomidine (0.5mcg/kg bolus load + 0.7mcg/kg/hr infusion)\n\nFentanyl: Fentanyl standard of care\n\nDexmedetomidine: Dexmedetomidine (0.5 mcg/kg + 0.7 mcg/kg/hr)'}], 'timeFrame': 'through day 7 of mechanical ventilation or initial extubation (whichever is first)', 'description': 'Characterize the exposure response relationships of fentanyl and dexmedetomidine when administered alone or in combination in children receiving mechanical ventilation. PK is known to be altered in children compared to adults, and in those with critical illness. Characterization of pharmacokinetic-pharmacodynamic relationships can improve dose optimization when dose may not be equivalent to plasma exposure and related effect. The RASS scale is a 10-point scale that ranges from -5 to +4 with -5=unarousable and +4=combative. Zero means the patient is alert and calm.', 'reportingStatus': 'POSTED', 'populationDescription': 'Data not collected. The study was terminated early due to enrollment challenges.'}, {'type': 'SECONDARY', 'title': 'Sedation Based on RASS Scale Relative to Dexmedetomidine Plasma Concentrations (AUC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Fen. SOC+Saline Placebo (Bolus+Infusion)', 'description': 'Fentanyl standard of care (SOC) titrated to sedation + saline placebo (bolus + infusion)\n\nFentanyl: Fentanyl standard of care'}, {'id': 'OG001', 'title': 'Fen. SOC+Dex.(.5mcg/kg + .25mcg/kg/hr)', 'description': 'Fentanyl SOC titrated to sedation + Dexmedetomidine (0.5mcg/kg bolus load + 0.2mcg/kg/hr infusion)\n\nFentanyl: Fentanyl standard of care\n\nDexmedetomidine: Dexmedetomidine (0.5 mcg/kg + 0.2 mcg/kg/hr)'}, {'id': 'OG002', 'title': 'Fen. SOC+Dex.(.5mcg/kg + .5mcg/kg/hr)', 'description': 'Fentanyl SOC titrated to sedation + Dexmedetomidine (0.5mcg/kg bolus load + 0.5mcg/kg/hr infusion)\n\nFentanyl: Fentanyl standard of care\n\nDexmedetomidine: Dexmedetomidine (0.5 mcg/kg + 0.5 mcg/kg/hr)'}, {'id': 'OG003', 'title': 'Fen. SOC+Dex.(.5mcg/kg + .75mcg/kg/hr)', 'description': 'Fentanyl SOC titrated to sedation + Dexmedetomidine (0.5mcg/kg bolus load + 0.7mcg/kg/hr infusion)\n\nFentanyl: Fentanyl standard of care\n\nDexmedetomidine: Dexmedetomidine (0.5 mcg/kg + 0.7 mcg/kg/hr)'}], 'timeFrame': 'through day 7 of mechanical ventilation or initial extubation (whichever is first)', 'description': 'Characterize the exposure response relationships of fentanyl and dexmedetomidine when administered alone or in combination in children receiving mechanical ventilation. PK is known to be altered in children compared to adults, and in those with critical illness. Characterization of pharmacokinetic-pharmacodynamic relationships can improve dose optimization when dose may not be equivalent to plasma exposure and related effect. The RASS scale is a 10-point scale that ranges from -5 to +4 with -5=unarousable and +4=combative. Zero means the patient is alert and calm.', 'reportingStatus': 'POSTED', 'populationDescription': 'Data not collected. The study was terminated early due to enrollment challenges.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Experiencing a Clinically Significant Episode of Hypotension', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Fen. SOC+Saline Placebo (Bolus+Infusion)', 'description': 'Fentanyl standard of care (SOC) titrated to sedation + saline placebo (bolus + infusion)\n\nFentanyl: Fentanyl standard of care'}, {'id': 'OG001', 'title': 'Fen. SOC+Dex.(.5mcg/kg + .25mcg/kg/hr)', 'description': 'Fentanyl SOC titrated to sedation + Dexmedetomidine (0.5mcg/kg bolus load + 0.2mcg/kg/hr infusion)\n\nFentanyl: Fentanyl standard of care\n\nDexmedetomidine: Dexmedetomidine (0.5 mcg/kg + 0.2 mcg/kg/hr)'}, {'id': 'OG002', 'title': 'Fen. SOC+Dex.(.5mcg/kg + .5mcg/kg/hr)', 'description': 'Fentanyl SOC titrated to sedation + Dexmedetomidine (0.5mcg/kg bolus load + 0.5mcg/kg/hr infusion)\n\nFentanyl: Fentanyl standard of care\n\nDexmedetomidine: Dexmedetomidine (0.5 mcg/kg + 0.5 mcg/kg/hr)'}, {'id': 'OG003', 'title': 'Fen. SOC+Dex.(.5mcg/kg + .75mcg/kg/hr)', 'description': 'Fentanyl SOC titrated to sedation + Dexmedetomidine (0.5mcg/kg bolus load + 0.7mcg/kg/hr infusion)\n\nFentanyl: Fentanyl standard of care\n\nDexmedetomidine: Dexmedetomidine (0.5 mcg/kg + 0.7 mcg/kg/hr)'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 28 days or until discharge from the ICU (whichever is first)', 'description': 'Characterize the safety profile of fentanyl and dexmedetomidine when administered alone or in combination to children receiving mechanical ventilation.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with data collected. No participants were enrolled in the Fen. SOC+Dex.(.5mcg/kg + .75mcg/kg/hr) group.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Experiencing SAEs (Serious Adverse Events)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Fen. SOC+Saline Placebo (Bolus+Infusion)', 'description': 'Fentanyl standard of care (SOC) titrated to sedation + saline placebo (bolus + infusion)\n\nFentanyl: Fentanyl standard of care'}, {'id': 'OG001', 'title': 'Fen. SOC+Dex.(.5mcg/kg + .25mcg/kg/hr)', 'description': 'Fentanyl SOC titrated to sedation + Dexmedetomidine (0.5mcg/kg bolus load + 0.2mcg/kg/hr infusion)\n\nFentanyl: Fentanyl standard of care\n\nDexmedetomidine: Dexmedetomidine (0.5 mcg/kg + 0.2 mcg/kg/hr)'}, {'id': 'OG002', 'title': 'Fen. SOC+Dex.(.5mcg/kg + .5mcg/kg/hr)', 'description': 'Fentanyl SOC titrated to sedation + Dexmedetomidine (0.5mcg/kg bolus load + 0.5mcg/kg/hr infusion)\n\nFentanyl: Fentanyl standard of care\n\nDexmedetomidine: Dexmedetomidine (0.5 mcg/kg + 0.5 mcg/kg/hr)'}, {'id': 'OG003', 'title': 'Fen. SOC+Dex.(.5mcg/kg + .75mcg/kg/hr)', 'description': 'Fentanyl SOC titrated to sedation + Dexmedetomidine (0.5mcg/kg bolus load + 0.7mcg/kg/hr infusion)\n\nFentanyl: Fentanyl standard of care\n\nDexmedetomidine: Dexmedetomidine (0.5 mcg/kg + 0.7 mcg/kg/hr)'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 28 days or until discharge from the ICU (whichever is first)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'No participants were enrolled in the Fen. SOC+Dex.(.5mcg/kg + .75mcg/kg/hr) group.'}, {'type': 'SECONDARY', 'title': 'Mean Number of SAEs (Serious Adverse Events) Experienced by Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Fen. SOC+Saline Placebo (Bolus+Infusion)', 'description': 'Fentanyl standard of care (SOC) titrated to sedation + saline placebo (bolus + infusion)\n\nFentanyl: Fentanyl standard of care'}, {'id': 'OG001', 'title': 'Fen. SOC+Dex.(.5mcg/kg + .25mcg/kg/hr)', 'description': 'Fentanyl SOC titrated to sedation + Dexmedetomidine (0.5mcg/kg bolus load + 0.2mcg/kg/hr infusion)\n\nFentanyl: Fentanyl standard of care\n\nDexmedetomidine: Dexmedetomidine (0.5 mcg/kg + 0.2 mcg/kg/hr)'}, {'id': 'OG002', 'title': 'Fen. SOC+Dex.(.5mcg/kg + .5mcg/kg/hr)', 'description': 'Fentanyl SOC titrated to sedation + Dexmedetomidine (0.5mcg/kg bolus load + 0.5mcg/kg/hr infusion)\n\nFentanyl: Fentanyl standard of care\n\nDexmedetomidine: Dexmedetomidine (0.5 mcg/kg + 0.5 mcg/kg/hr)'}, {'id': 'OG003', 'title': 'Fen. SOC+Dex.(.5mcg/kg + .75mcg/kg/hr)', 'description': 'Fentanyl SOC titrated to sedation + Dexmedetomidine (0.5mcg/kg bolus load + 0.7mcg/kg/hr infusion)\n\nFentanyl: Fentanyl standard of care\n\nDexmedetomidine: Dexmedetomidine (0.5 mcg/kg + 0.7 mcg/kg/hr)'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'spread': '0', 'groupId': 'OG001'}, {'value': '1', 'spread': 'NA', 'comment': 'Only one participant experienced an SAE.', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'up to 28 days or until discharge from the ICU (whichever is first)', 'unitOfMeasure': 'serious adverse events', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who experienced at least one SAE. No participants were enrolled in the Fen. SOC+Dex.(.5mcg/kg + .75mcg/kg/hr) group.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Experiencing a Clinically Significant Episode of Bradycardia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Fen. SOC+Saline Placebo (Bolus+Infusion)', 'description': 'Fentanyl standard of care (SOC) titrated to sedation + saline placebo (bolus + infusion)\n\nFentanyl: Fentanyl standard of care'}, {'id': 'OG001', 'title': 'Fen. SOC+Dex.(.5mcg/kg + .25mcg/kg/hr)', 'description': 'Fentanyl SOC titrated to sedation + Dexmedetomidine (0.5mcg/kg bolus load + 0.2mcg/kg/hr infusion)\n\nFentanyl: Fentanyl standard of care\n\nDexmedetomidine: Dexmedetomidine (0.5 mcg/kg + 0.2 mcg/kg/hr)'}, {'id': 'OG002', 'title': 'Fen. SOC+Dex.(.5mcg/kg + .5mcg/kg/hr)', 'description': 'Fentanyl SOC titrated to sedation + Dexmedetomidine (0.5mcg/kg bolus load + 0.5mcg/kg/hr infusion)\n\nFentanyl: Fentanyl standard of care\n\nDexmedetomidine: Dexmedetomidine (0.5 mcg/kg + 0.5 mcg/kg/hr)'}, {'id': 'OG003', 'title': 'Fen. SOC+Dex.(.5mcg/kg + .75mcg/kg/hr)', 'description': 'Fentanyl SOC titrated to sedation + Dexmedetomidine (0.5mcg/kg bolus load + 0.7mcg/kg/hr infusion)\n\nFentanyl: Fentanyl standard of care\n\nDexmedetomidine: Dexmedetomidine (0.5 mcg/kg + 0.7 mcg/kg/hr)'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 28 days or until discharge from the ICU (whichever is first)', 'description': 'Characterize the safety profile of fentanyl and dexmedetomidine when administered alone or in combination to children receiving mechanical ventilation.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with data collected. No participants were enrolled in the Fen. SOC+Dex.(.5mcg/kg + .75mcg/kg/hr) group.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Experiencing a Clinically Significant Episode of Urinary Retention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Fen. SOC+Saline Placebo (Bolus+Infusion)', 'description': 'Fentanyl standard of care (SOC) titrated to sedation + saline placebo (bolus + infusion)\n\nFentanyl: Fentanyl standard of care'}, {'id': 'OG001', 'title': 'Fen. SOC+Dex.(.5mcg/kg + .25mcg/kg/hr)', 'description': 'Fentanyl SOC titrated to sedation + Dexmedetomidine (0.5mcg/kg bolus load + 0.2mcg/kg/hr infusion)\n\nFentanyl: Fentanyl standard of care\n\nDexmedetomidine: Dexmedetomidine (0.5 mcg/kg + 0.2 mcg/kg/hr)'}, {'id': 'OG002', 'title': 'Fen. SOC+Dex.(.5mcg/kg + .5mcg/kg/hr)', 'description': 'Fentanyl SOC titrated to sedation + Dexmedetomidine (0.5mcg/kg bolus load + 0.5mcg/kg/hr infusion)\n\nFentanyl: Fentanyl standard of care\n\nDexmedetomidine: Dexmedetomidine (0.5 mcg/kg + 0.5 mcg/kg/hr)'}, {'id': 'OG003', 'title': 'Fen. SOC+Dex.(.5mcg/kg + .75mcg/kg/hr)', 'description': 'Fentanyl SOC titrated to sedation + Dexmedetomidine (0.5mcg/kg bolus load + 0.7mcg/kg/hr infusion)\n\nFentanyl: Fentanyl standard of care\n\nDexmedetomidine: Dexmedetomidine (0.5 mcg/kg + 0.7 mcg/kg/hr)'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 28 days or until discharge from the ICU (whichever is first)', 'description': 'Characterize the safety profile of fentanyl and dexmedetomidine when administered alone or in combination to children receiving mechanical ventilation.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with data collected. No participants were enrolled in the Fen. SOC+Dex.(.5mcg/kg + .75mcg/kg/hr) group.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Average Daily Cornell Assessment of Pediatrics in Delirium (CAPD) Scores', 'timeFrame': 'through day 7 of mechanical ventilation or initial extubation (whichever is first)', 'description': 'Estimate the incidence of intensive care unit delirium in children exposed to fentanyl and dexmedetomidine alone or in combination when receiving mechanical ventilation. (Measures of delirium). The CAPD scale goes from 0-4 and has 8 questions. All items scored as occurring never, rarely, sometimes, often, or always. Individual item scores are added for a sum total score.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Maximum Daily CAPD Scores', 'timeFrame': 'through day 7 of mechanical ventilation or initial extubation (whichever is first)', 'description': 'Estimate the incidence of intensive care unit delirium in children exposed to fentanyl and dexmedetomidine alone or in combination when receiving mechanical ventilation. (Measures of delirium). The CAPD scale goes from 0-4 and has 8 questions. All items scored as occurring never, rarely, sometimes, often, or always. Individual item scores are added for a sum total score.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Minimum Daily CAPD Scores', 'timeFrame': 'through day 7 of mechanical ventilation or initial extubation (whichever is first)', 'description': 'Estimate the incidence of intensive care unit delirium in children exposed to fentanyl and dexmedetomidine alone or in combination when receiving mechanical ventilation. (Measures of delirium). The CAPD scale goes from 0-4 and has 8 questions. All items scored as occurring never, rarely, sometimes, often, or always. Individual item scores are added for a sum total score.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Average Daily Withdrawal Assessment Tool (WAT-1) Score', 'timeFrame': 'through day 7 of mechanical ventilation or initial extubation (whichever is first)', 'description': 'Estimate the incidence of opioid withdrawal syndrome in children exposed to fentanyl and dexmedetomidine when administered alone or in combination when receiving mechanical ventilation. (Measures of withdrawal). WAT-1 scale is 0=no/none and 1=yes/moderate/severe. Total score is on a 0-12 scale where lower is better.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Minimum Daily WAT-1 Score', 'timeFrame': 'through day 7 of mechanical ventilation or initial extubation (whichever is first)', 'description': 'Estimate the incidence of opioid withdrawal syndrome in children exposed to fentanyl and dexmedetomidine when administered alone or in combination when receiving mechanical ventilation. (Measures of withdrawal). WAT-1 scale is 0=no/none and 1=yes/moderate/severe. Total score is on a 0-12 scale where lower is better.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Maximum Daily WAT-1 Score', 'timeFrame': 'through day 7 of mechanical ventilation or initial extubation (whichever is first)', 'description': 'Estimate the incidence of opioid withdrawal syndrome in children exposed to fentanyl and dexmedetomidine when administered alone or in combination when receiving mechanical ventilation. (Measures of withdrawal). WAT-1 scale is 0=no/none and 1=yes/moderate/severe. Total score is on a 0-12 scale where lower is better.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Fen. SOC+Saline Placebo (Bolus+Infusion)', 'description': 'Fentanyl standard of care (SOC) titrated to sedation + saline placebo (bolus + infusion)\n\nFentanyl: Fentanyl standard of care'}, {'id': 'FG001', 'title': 'Fen. SOC+Dex.(.5mcg/kg + .25mcg/kg/hr)', 'description': 'Fentanyl SOC titrated to sedation + Dexmedetomidine (0.5mcg/kg bolus load + 0.2mcg/kg/hr infusion)\n\nFentanyl: Fentanyl standard of care\n\nDexmedetomidine: Dexmedetomidine (0.5 mcg/kg + 0.2 mcg/kg/hr)'}, {'id': 'FG002', 'title': 'Fen. SOC+Dex.(.5mcg/kg + .5mcg/kg/hr)', 'description': 'Fentanyl SOC titrated to sedation + Dexmedetomidine (0.5mcg/kg bolus load + 0.5mcg/kg/hr infusion)\n\nFentanyl: Fentanyl standard of care\n\nDexmedetomidine: Dexmedetomidine (0.5 mcg/kg + 0.5 mcg/kg/hr)'}, {'id': 'FG003', 'title': 'Fen. SOC+Dex.(.5mcg/kg + .75mcg/kg/hr)', 'description': 'Fentanyl SOC titrated to sedation + Dexmedetomidine (0.5mcg/kg bolus load + 0.7mcg/kg/hr infusion)\n\nFentanyl: Fentanyl standard of care\n\nDexmedetomidine: Dexmedetomidine (0.5 mcg/kg + 0.7 mcg/kg/hr)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '12'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '12'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Subjects enrolled were in a pediatric intensive care setting, critically ill and requiring ventilatory support and pain management associated with such.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '30', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Fen. SOC+Saline Placebo (Bolus+Infusion)', 'description': 'Fentanyl standard of care (SOC) titrated to sedation + saline placebo (bolus + infusion)\n\nFentanyl: Fentanyl standard of care'}, {'id': 'BG001', 'title': 'Fen. SOC+Dex.(.5mcg/kg + .25mcg/kg/hr)', 'description': 'Fentanyl SOC titrated to sedation + Dexmedetomidine (0.5mcg/kg bolus load + 0.2mcg/kg/hr infusion)\n\nFentanyl: Fentanyl standard of care\n\nDexmedetomidine: Dexmedetomidine (0.5 mcg/kg + 0.2 mcg/kg/hr)'}, {'id': 'BG002', 'title': 'Fen. SOC+Dex.(.5mcg/kg + .5mcg/kg/hr)', 'description': 'Fentanyl SOC titrated to sedation + Dexmedetomidine (0.5mcg/kg bolus load + 0.5mcg/kg/hr infusion)\n\nFentanyl: Fentanyl standard of care\n\nDexmedetomidine: Dexmedetomidine (0.5 mcg/kg + 0.5 mcg/kg/hr)'}, {'id': 'BG003', 'title': 'Fen. SOC+Dex.(.5mcg/kg + .75mcg/kg/hr)', 'description': 'Fentanyl SOC titrated to sedation + Dexmedetomidine (0.5mcg/kg bolus load + 0.7mcg/kg/hr infusion)\n\nFentanyl: Fentanyl standard of care\n\nDexmedetomidine: Dexmedetomidine (0.5 mcg/kg + 0.7 mcg/kg/hr)'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '3.8', 'spread': '6.8', 'groupId': 'BG000'}, {'value': '2.5', 'spread': '2.8', 'groupId': 'BG001'}, {'value': '2.6', 'spread': '3.7', 'groupId': 'BG002'}, {'value': '2.8', 'spread': '4.0', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG004'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '26', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '19', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '30', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Study was prematurely terminated and no participants were enrolled in the Fen. SOC+Dex.(.5mcg/kg + .75mcg/kg/hr) group.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-06-10', 'size': 620518, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-08-30T11:44', 'hasProtocol': True}, {'date': '2020-04-16', 'size': 534143, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2021-02-04T10:58', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'Phase 1b randomized, double-blind, placebo-controlled dose escalation trial. The study will randomize participants to receive placebo (fentanyl standard of care) titrated to sedation+saline placebo (bolus+infusion) or one of the following 3 Dexmedetomidine treatment arms in a sequential cohort fashion: Cohort 1: Fentanyl SOC titrated to sedation + Dexmedetomidine (0.5mcg/kg bolus load + 0.2 mcg/kg/hr infusion); Cohort 2: Fentanyl SOC titrated to sedation + Dexmedetomidine (0.5mcg/kg bolus load + 0.5mcg/kg/hr infusion); Cohort 3: Fentanyl SOC titrated to sedation + Dexmedetomidine (0.5mcg/kg bolus load + 0.7mcg/kg/hr infusion).'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'whyStopped': 'Enrollment challenging during the pandemic COVID 19', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2019-07-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2020-11-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-07', 'studyFirstSubmitDate': '2019-04-25', 'resultsFirstSubmitDate': '2021-09-02', 'studyFirstSubmitQcDate': '2019-05-02', 'lastUpdatePostDateStruct': {'date': '2021-11-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-10-07', 'studyFirstPostDateStruct': {'date': '2019-05-06', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-11-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Average Daily Cornell Assessment of Pediatrics in Delirium (CAPD) Scores', 'timeFrame': 'through day 7 of mechanical ventilation or initial extubation (whichever is first)', 'description': 'Estimate the incidence of intensive care unit delirium in children exposed to fentanyl and dexmedetomidine alone or in combination when receiving mechanical ventilation. (Measures of delirium). The CAPD scale goes from 0-4 and has 8 questions. All items scored as occurring never, rarely, sometimes, often, or always. Individual item scores are added for a sum total score.'}, {'measure': 'Maximum Daily CAPD Scores', 'timeFrame': 'through day 7 of mechanical ventilation or initial extubation (whichever is first)', 'description': 'Estimate the incidence of intensive care unit delirium in children exposed to fentanyl and dexmedetomidine alone or in combination when receiving mechanical ventilation. (Measures of delirium). The CAPD scale goes from 0-4 and has 8 questions. All items scored as occurring never, rarely, sometimes, often, or always. Individual item scores are added for a sum total score.'}, {'measure': 'Minimum Daily CAPD Scores', 'timeFrame': 'through day 7 of mechanical ventilation or initial extubation (whichever is first)', 'description': 'Estimate the incidence of intensive care unit delirium in children exposed to fentanyl and dexmedetomidine alone or in combination when receiving mechanical ventilation. (Measures of delirium). The CAPD scale goes from 0-4 and has 8 questions. All items scored as occurring never, rarely, sometimes, often, or always. Individual item scores are added for a sum total score.'}, {'measure': 'Average Daily Withdrawal Assessment Tool (WAT-1) Score', 'timeFrame': 'through day 7 of mechanical ventilation or initial extubation (whichever is first)', 'description': 'Estimate the incidence of opioid withdrawal syndrome in children exposed to fentanyl and dexmedetomidine when administered alone or in combination when receiving mechanical ventilation. (Measures of withdrawal). WAT-1 scale is 0=no/none and 1=yes/moderate/severe. Total score is on a 0-12 scale where lower is better.'}, {'measure': 'Minimum Daily WAT-1 Score', 'timeFrame': 'through day 7 of mechanical ventilation or initial extubation (whichever is first)', 'description': 'Estimate the incidence of opioid withdrawal syndrome in children exposed to fentanyl and dexmedetomidine when administered alone or in combination when receiving mechanical ventilation. (Measures of withdrawal). WAT-1 scale is 0=no/none and 1=yes/moderate/severe. Total score is on a 0-12 scale where lower is better.'}, {'measure': 'Maximum Daily WAT-1 Score', 'timeFrame': 'through day 7 of mechanical ventilation or initial extubation (whichever is first)', 'description': 'Estimate the incidence of opioid withdrawal syndrome in children exposed to fentanyl and dexmedetomidine when administered alone or in combination when receiving mechanical ventilation. (Measures of withdrawal). WAT-1 scale is 0=no/none and 1=yes/moderate/severe. Total score is on a 0-12 scale where lower is better.'}], 'primaryOutcomes': [{'measure': 'Mean Daily Dose of Fentanyl in mcg/kg/hr (Micrograms Per Kilogram Per Hour)', 'timeFrame': 'through day 7 of mechanical ventilation or initial extubation (whichever is first)', 'description': 'Characterize the opioid-sparing effect of dexmedetomidine when co-administered with fentanyl in children receiving mechanical ventilation. Characterization of differences between dosing exposures for the four groups will allow estimation of the opioid-sparing effect of dexmedetomidine.'}], 'secondaryOutcomes': [{'measure': 'Sedation Based on the State Behavior Scale (SBS) Relative to Fentanyl Plasma Concentrations (Cmax)', 'timeFrame': 'through day 7 of mechanical ventilation or initial extubation (whichever is first)', 'description': 'Characterize the exposure response relationships of fentanyl and dexmedetomidine when administered alone or in combination in children receiving mechanical ventilation. PK is known to be altered in children compared to adults, and in those with critical illness. Characterization of pharmacokinetic-pharmacodynamic relationships can improve dose optimization when dose may not be equivalent to plasma exposure and related effect. The SBS is a 6-point scale that ranges from +2 to -3 with -3. Scores that are more negative reflect a more sedated state (-3). Scores that are more positive reflect a more agitated state (+2). Zero is awake and easily calmed.'}, {'measure': 'Sedation Based on SBS Scale Relative to Fentanyl Plasma Concentrations (Cmin)', 'timeFrame': 'through day 7 of mechanical ventilation or initial extubation (whichever is first)', 'description': 'Characterize the exposure response relationships of fentanyl and dexmedetomidine when administered alone or in combination in children receiving mechanical ventilation. PK is known to be altered in children compared to adults, and in those with critical illness. Characterization of pharmacokinetic-pharmacodynamic relationships can improve dose optimization when dose may not be equivalent to plasma exposure and related effect. The SBS is a 6-point scale that ranges from +2 to -3 with -3. Scores that are more negative reflect a more sedated state (-3). Scores that are more positive reflect a more agitated state (+2). Zero is awake and easily calmed.'}, {'measure': 'Sedation Based on SBS Scale Relative to Fentanyl Plasma Concentrations (Css)', 'timeFrame': 'through day 7 of mechanical ventilation or initial extubation (whichever is first)', 'description': 'Characterize the exposure response relationships of fentanyl and dexmedetomidine when administered alone or in combination in children receiving mechanical ventilation. PK is known to be altered in children compared to adults, and in those with critical illness. Characterization of pharmacokinetic-pharmacodynamic relationships can improve dose optimization when dose may not be equivalent to plasma exposure and related effect. The SBS is a 6-point scale that ranges from +2 to -3 with -3. Scores that are more negative reflect a more sedated state (-3). Scores that are more positive reflect a more agitated state (+2). Zero is awake and easily calmed.'}, {'measure': 'Sedation Based on SBS Scale Relative to Fentanyl Plasma Concentrations (AUC)', 'timeFrame': 'through day 7 of mechanical ventilation or initial extubation (whichever is first)', 'description': 'Characterize the exposure response relationships of fentanyl and dexmedetomidine when administered alone or in combination in children receiving mechanical ventilation. PK is known to be altered in children compared to adults, and in those with critical illness. Characterization of pharmacokinetic-pharmacodynamic relationships can improve dose optimization when dose may not be equivalent to plasma exposure and related effect. The SBS is a 6-point scale that ranges from +2 to -3 with -3. Scores that are more negative reflect a more sedated state (-3). Scores that are more positive reflect a more agitated state (+2). Zero is awake and easily calmed.'}, {'measure': 'Sedation Based on SBS Scale Relative to Dexmedetomidine Plasma Concentrations (Cmax)', 'timeFrame': 'through day 7 of mechanical ventilation or initial extubation (whichever is first)', 'description': 'Characterize the exposure response relationships of fentanyl and dexmedetomidine when administered alone or in combination in children receiving mechanical ventilation. PK is known to be altered in children compared to adults, and in those with critical illness. Characterization of pharmacokinetic-pharmacodynamic relationships can improve dose optimization when dose may not be equivalent to plasma exposure and related effect. The SBS is a 6-point scale that ranges from +2 to -3 with -3. Scores that are more negative reflect a more sedated state (-3). Scores that are more positive reflect a more agitated state (+2). Zero is awake and easily calmed.'}, {'measure': 'Sedation Based on SBS Scale Relative to Dexmedetomidine Plasma Concentrations (Cmin)', 'timeFrame': 'through day 7 of mechanical ventilation or initial extubation (whichever is first)', 'description': 'Characterize the exposure response relationships of fentanyl and dexmedetomidine when administered alone or in combination in children receiving mechanical ventilation. PK is known to be altered in children compared to adults, and in those with critical illness. Characterization of pharmacokinetic-pharmacodynamic relationships can improve dose optimization when dose may not be equivalent to plasma exposure and related effect. The SBS is a 6-point scale that ranges from +2 to -3 with -3. Scores that are more negative reflect a more sedated state (-3). Scores that are more positive reflect a more agitated state (+2). Zero is awake and easily calmed.'}, {'measure': 'Sedation Based on SBS Scale Relative to Dexmedetomidine Plasma Concentrations (Css)', 'timeFrame': 'through day 7 of mechanical ventilation or initial extubation (whichever is first)', 'description': 'Characterize the exposure response relationships of fentanyl and dexmedetomidine when administered alone or in combination in children receiving mechanical ventilation. PK is known to be altered in children compared to adults, and in those with critical illness. Characterization of pharmacokinetic-pharmacodynamic relationships can improve dose optimization when dose may not be equivalent to plasma exposure and related effect. The SBS is a 6-point scale that ranges from +2 to -3 with -3. Scores that are more negative reflect a more sedated state (-3). Scores that are more positive reflect a more agitated state (+2). Zero is awake and easily calmed.'}, {'measure': 'Sedation Based on SBS Scale Relative to Dexmedetomidine Plasma Concentrations (AUC)', 'timeFrame': 'through day 7 of mechanical ventilation or initial extubation (whichever is first)', 'description': 'Characterize the exposure response relationships of fentanyl and dexmedetomidine when administered alone or in combination in children receiving mechanical ventilation. PK is known to be altered in children compared to adults, and in those with critical illness. Characterization of pharmacokinetic-pharmacodynamic relationships can improve dose optimization when dose may not be equivalent to plasma exposure and related effect. The SBS is a 6-point scale that ranges from +2 to -3 with -3. Scores that are more negative reflect a more sedated state (-3). Scores that are more positive reflect a more agitated state (+2). Zero is awake and easily calmed.'}, {'measure': 'Sedation Based on Richmond Agitation and Sedation Scale (RASS) Scale Relative to Fentanyl Plasma Concentrations (Cmax)', 'timeFrame': 'through day 7 of mechanical ventilation or initial extubation (whichever is first)', 'description': 'Characterize the exposure response relationships of fentanyl and dexmedetomidine when administered alone or in combination in children receiving mechanical ventilation. PK is known to be altered in children compared to adults, and in those with critical illness. Characterization of pharmacokinetic-pharmacodynamic relationships can improve dose optimization when dose may not be equivalent to plasma exposure and related effect. The RASS is a 10-point scale that ranges from -5 to +4 with -5=unarousable and +4=combative. Zero means the patient is alert and calm.'}, {'measure': 'Sedation Based on RASS Scale Relative to Fentanyl Plasma Concentrations (Cmin)', 'timeFrame': 'through day 7 of mechanical ventilation or initial extubation (whichever is first)', 'description': 'Characterize the exposure response relationships of fentanyl and dexmedetomidine when administered alone or in combination in children receiving mechanical ventilation. PK is known to be altered in children compared to adults, and in those with critical illness. Characterization of pharmacokinetic-pharmacodynamic relationships can improve dose optimization when dose may not be equivalent to plasma exposure and related effect. The RASS scale is a 10-pint scale that ranges from -5 to +4 with -5=unarousable and +4=combative. Zero means the patient is alert and calm.'}, {'measure': 'Sedation Based on RASS Scale Relative to Fentanyl Plasma Concentrations (Css)', 'timeFrame': 'through day 7 of mechanical ventilation or initial extubation (whichever is first)', 'description': 'Characterize the exposure response relationships of fentanyl and dexmedetomidine when administered alone or in combination in children receiving mechanical ventilation. PK is known to be altered in children compared to adults, and in those with critical illness. Characterization of pharmacokinetic-pharmacodynamic relationships can improve dose optimization when dose may not be equivalent to plasma exposure and related effect. The RASS scale is a 10-point scale that ranges from -5 to +4 with -5=unarousable and +4=combative. Zero means the patient is alert and calm.'}, {'measure': 'Sedation Based on RASS Scale Relative to Fentanyl Plasma Concentrations (AUC)', 'timeFrame': 'through day 7 of mechanical ventilation or initial extubation (whichever is first)', 'description': 'Characterize the exposure response relationships of fentanyl and dexmedetomidine when administered alone or in combination in children receiving mechanical ventilation. PK is known to be altered in children compared to adults, and in those with critical illness. Characterization of pharmacokinetic-pharmacodynamic relationships can improve dose optimization when dose may not be equivalent to plasma exposure and related effect. The RASS scale is a 10-point scale that ranges from -5 to +4 with -5=unarousable and +4=combative. Zero means the patient is alert and calm.'}, {'measure': 'Sedation Based on RASS Scale Relative to Dexmedetomidine Plasma Concentrations (Cmax)', 'timeFrame': 'through day 7 of mechanical ventilation or initial extubation (whichever is first)', 'description': 'Characterize the exposure response relationships of fentanyl and dexmedetomidine when administered alone or in combination in children receiving mechanical ventilation. PK is known to be altered in children compared to adults, and in those with critical illness. Characterization of pharmacokinetic-pharmacodynamic relationships can improve dose optimization when dose may not be equivalent to plasma exposure and related effect. The RASS scale is a 10-point scale that ranges from -5 to +4 with -5=unarousable and +4=combative. Zero means the patient is alert and calm.'}, {'measure': 'Sedation Based on RASS Scale Relative to Dexmedetomidine Plasma Concentrations (Cmin)', 'timeFrame': 'through day 7 of mechanical ventilation or initial extubation (whichever is first)', 'description': 'Characterize the exposure response relationships of fentanyl and dexmedetomidine when administered alone or in combination in children receiving mechanical ventilation. PK is known to be altered in children compared to adults, and in those with critical illness. Characterization of pharmacokinetic-pharmacodynamic relationships can improve dose optimization when dose may not be equivalent to plasma exposure and related effect. The RASS scale is a 10-point scale that ranges from -5 to +4 with -5=unarousable and +4=combative. Zero means the patient is alert and calm.'}, {'measure': 'Sedation Based on RASS Scale Relative to Dexmedetomidine Plasma Concentrations (Css)', 'timeFrame': 'through day 7 of mechanical ventilation or initial extubation (whichever is first)', 'description': 'Characterize the exposure response relationships of fentanyl and dexmedetomidine when administered alone or in combination in children receiving mechanical ventilation. PK is known to be altered in children compared to adults, and in those with critical illness. Characterization of pharmacokinetic-pharmacodynamic relationships can improve dose optimization when dose may not be equivalent to plasma exposure and related effect. The RASS scale is a 10-point scale that ranges from -5 to +4 with -5=unarousable and +4=combative. Zero means the patient is alert and calm.'}, {'measure': 'Sedation Based on RASS Scale Relative to Dexmedetomidine Plasma Concentrations (AUC)', 'timeFrame': 'through day 7 of mechanical ventilation or initial extubation (whichever is first)', 'description': 'Characterize the exposure response relationships of fentanyl and dexmedetomidine when administered alone or in combination in children receiving mechanical ventilation. PK is known to be altered in children compared to adults, and in those with critical illness. Characterization of pharmacokinetic-pharmacodynamic relationships can improve dose optimization when dose may not be equivalent to plasma exposure and related effect. The RASS scale is a 10-point scale that ranges from -5 to +4 with -5=unarousable and +4=combative. Zero means the patient is alert and calm.'}, {'measure': 'Number of Participants Experiencing a Clinically Significant Episode of Hypotension', 'timeFrame': 'up to 28 days or until discharge from the ICU (whichever is first)', 'description': 'Characterize the safety profile of fentanyl and dexmedetomidine when administered alone or in combination to children receiving mechanical ventilation.'}, {'measure': 'Number of Participants Experiencing SAEs (Serious Adverse Events)', 'timeFrame': 'up to 28 days or until discharge from the ICU (whichever is first)'}, {'measure': 'Mean Number of SAEs (Serious Adverse Events) Experienced by Participants', 'timeFrame': 'up to 28 days or until discharge from the ICU (whichever is first)'}, {'measure': 'Number of Participants Experiencing a Clinically Significant Episode of Bradycardia', 'timeFrame': 'up to 28 days or until discharge from the ICU (whichever is first)', 'description': 'Characterize the safety profile of fentanyl and dexmedetomidine when administered alone or in combination to children receiving mechanical ventilation.'}, {'measure': 'Number of Participants Experiencing a Clinically Significant Episode of Urinary Retention', 'timeFrame': 'up to 28 days or until discharge from the ICU (whichever is first)', 'description': 'Characterize the safety profile of fentanyl and dexmedetomidine when administered alone or in combination to children receiving mechanical ventilation.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dexmedetomidine', 'Mechanical Ventilation Complication', 'Critically Ill']}, 'referencesModule': {'references': [{'pmid': '36577492', 'type': 'DERIVED', 'citation': 'Boutzoukas AE, Olson R, Sellers MA, Fischer G, Hornik CD, Alibrahim O, Iheagwara K, Abulebda K, Bass AL, Irby K, Subbaswamy A, Zivick EE, Sweney J, Stormorken AG, Barker EE, Lutfi R, McCrory MC, Costello JM, Ackerman KG, Munoz Pareja JC, Dean JM, Abdelsamad N, Hanley DF Jr, Mould WA, Lane K, Stroud M, Feger BJ, Greenberg RG, Smith PB, Benjamin DK Jr, Hornik CP, Zimmerman KO, Becker ML. Mechanisms to expedite pediatric clinical trial site activation: The DOSE trial experience. Contemp Clin Trials. 2023 Feb;125:107067. doi: 10.1016/j.cct.2022.107067. Epub 2022 Dec 25.'}]}, 'descriptionModule': {'briefSummary': 'Multicenter, double blind randomized controlled trial of fentanyl vs. fentanyl + dexmedetomidine as the initial regimen for maintenance of sedation in mechanically-ventilated, critically ill children.\n\nThis trial will evaluate the opioid-sparing effect of dexmedetomidine when administered with fentanyl to mechanically ventilated, critically ill children. Study drug or placebo will be administered with fentanyl, which will be titrated to achieve sedation scores consistent with response to light touch. Plasma samples and bedside assessments for pain, sedation, and delirium will be collected.', 'detailedDescription': 'Phase 1b randomized, double-blind, placebo-controlled dose escalation trial of sedation regimens in critically ill children. Testing the hypothesis of mean daily fentanyl dose through day 7 of mechanical ventilation will be reduced by ≥25% by the addition of dexmedetomidine to fentanyl therapy. This trial will involve multiple clinical sites. Randomization will occur by individual and investigators will be blinded to study/treatment arm. The statistical analysis will account for center effects, participant characteristics (including post-surgical state), and changes over time to minimize bias. In addition, PIs and study coordinators will undergo training to standardize assessment procedures. The study will randomize participants to receive placebo (fentanyl standard of care) titrated to sedation+saline placebo (bolus+infusion) or one of the following 3 Dexmedetomidine treatment arms in a sequential cohort fashion: Cohort 1: Fentanyl SOC titrated to sedation + Dexmedetomidine (0.5mcg/kg bolus load + 0.2 mcg/kg/hr infusion); Cohort 2: Fentanyl SOC titrated to sedation + Dexmedetomidine (0.5mcg/kg bolus load + 0.5mcg/kg/hr infusion); and, Cohort 3: Fentanyl SOC titrated to sedation + Dexmedetomidine (0.5mcg/kg bolus load + 0.7mcg/kg/hr infusion).\n\nAn interim analysis is planned for this trial.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Ages 0 to \\<18 years at the time of enrollment.\n2. If \\< 6 months postnatal age, gestational age ≥ 35 weeks.\n3. Admitted to an intensive care unit.\n4. Planned or anticipated mechanically ventilation for ≥2 days.\n5. Require sedation to maintain mechanical ventilation per clinical judgment.\n6. No contraindication to receipt of fentanyl or dexmedetomidine per clinician judgment.\n7. Availability and willingness of the parent/legal guardian to provide written informed consent.\n\nExclusion Criteria:\n\n1. Previous participation in this study.\n2. Severe traumatic brain injury as the underlying etiology for critical illness requiring mechanical ventilation or baseline pediatric cerebral performance category (PCPC) \\>3.\n3. Planned receipt of sedatives other than fentanyl or dexmedetomidine.\n4. Anticipated receipt of neuromuscular blockade for \\>48 consecutive hours during the study period.\n5. Receipt of fentanyl or dexmedetomidine via continuous infusion for \\>12 hours in the 24 hours prior to enrollment.\n6. Extracorporeal life support (including renal replacement therapy, extracorporeal membrane oxygenation, ventricular assist device, etc.) at the time of enrollment.\n7. Chronic use of or recent overdose of serotonergic agents (selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), monoamine oxidase (MAO) inhibitors, cyclic antidepressants)\n8. Known pregnancy\n9. Known liver dysfunction, defined as: aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \\>2x the upper limit of normal for age\n10. Known or impending renal failure defined as: anuria \\> or equal to 12 hours prior to enrollment or requiring renal replacement therapy\n11. High risk children, define as: a. known heart block b. known bradyarrythmia including clinically significant bradycardia (defined as requiring chronotropic agents or cardiac pacing to treat)\n12. Receipt of mechanical ventilation during an admission for cardiac surgery\n\nNote: receipt of drugs other than fentanyl or dexmedetomidine for intubation, and receipt of neuromuscular blockage for intubation, will not be considered exclusionary criteria.'}, 'identificationModule': {'nctId': 'NCT03938857', 'acronym': 'DOSE', 'briefTitle': 'DOSE Trial of Opioid Sparing Effect', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'DEXMEDETOMIDINE OPIOID SPARING EFFECT IN MECHANICALLY VENTILATED CHILDREN: Phase 1b, Multicenter, Double Blind Randomized Controlled Dose Escalating Trial of Fentanyl vs. Fentanyl + Dexmedetomidine as the Initial Regimen for Maintenance of Sedation in Mechanically-ventilated, Critically Ill Children', 'orgStudyIdInfo': {'id': 'Pro00102267'}, 'secondaryIdInfos': [{'id': '5U24TR001608', 'link': 'https://reporter.nih.gov/quickSearch/5U24TR001608', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Fen. SOC+saline placebo (bolus+infusion)', 'description': 'Fentanyl standard of care (SOC) titrated to sedation + saline placebo (bolus + infusion)', 'interventionNames': ['Drug: Fentanyl']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Fen. SOC+Dex.(.5mcg/kg + .25mcg/kg/hr)', 'description': 'Fentanyl SOC titrated to sedation + Dexmedetomidine (0.5mcg/kg bolus load + 0.2mcg/kg/hr infusion)', 'interventionNames': ['Drug: Fentanyl', 'Drug: Dexmedetomidine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Fen. SOC+Dex.(.5mcg/kg + .5mcg/kg/hr)', 'description': 'Fentanyl SOC titrated to sedation + Dexmedetomidine (0.5mcg/kg bolus load + 0.5mcg/kg/hr infusion)', 'interventionNames': ['Drug: Fentanyl', 'Drug: Dexmedetomidine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Fen. SOC+Dex.(.5mcg/kg + .75mcg/kg/hr)', 'description': 'Fentanyl SOC titrated to sedation + Dexmedetomidine (0.5mcg/kg bolus load + 0.7mcg/kg/hr infusion)', 'interventionNames': ['Drug: Fentanyl', 'Drug: Dexmedetomidine']}], 'interventions': [{'name': 'Fentanyl', 'type': 'DRUG', 'description': 'Fentanyl standard of care', 'armGroupLabels': ['Fen. SOC+Dex.(.5mcg/kg + .25mcg/kg/hr)', 'Fen. SOC+Dex.(.5mcg/kg + .5mcg/kg/hr)', 'Fen. SOC+Dex.(.5mcg/kg + .75mcg/kg/hr)', 'Fen. SOC+saline placebo (bolus+infusion)']}, {'name': 'Dexmedetomidine', 'type': 'DRUG', 'description': 'Dexmedetomidine (0.5 mcg/kg + 0.2 mcg/kg/hr)', 'armGroupLabels': ['Fen. SOC+Dex.(.5mcg/kg + .25mcg/kg/hr)']}, {'name': 'Dexmedetomidine', 'type': 'DRUG', 'description': 'Dexmedetomidine (0.5 mcg/kg + 0.5 mcg/kg/hr)', 'armGroupLabels': ['Fen. SOC+Dex.(.5mcg/kg + .5mcg/kg/hr)']}, {'name': 'Dexmedetomidine', 'type': 'DRUG', 'description': 'Dexmedetomidine (0.5 mcg/kg + 0.7 mcg/kg/hr)', 'armGroupLabels': ['Fen. SOC+Dex.(.5mcg/kg + .75mcg/kg/hr)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72202', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': "Arkansas Children's Hospital", 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '32608', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': "University of Florida, Shands Children's Hospital", 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana University Health, Riley Hospital for Children', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '70808', 'city': 'Baton Rouge', 'state': 'Louisiana', 'country': 'United States', 'facility': "Our Lady of the Lake Children's Hospital", 'geoPoint': {'lat': 30.44332, 'lon': -91.18747}}, {'zip': '01655', 'city': 'Worcester', 'state': 'Massachusetts', 'country': 'United States', 'facility': "UMass Memorial Medical Center, Children's Center", 'geoPoint': {'lat': 42.26259, 'lon': -71.80229}}, {'zip': '55454', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': "University of Minnesota Masonic Children's Hospital", 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '63104', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': "Saint Louis University, Cardinal Glennon Children's Hospital", 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '87131', 'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'facility': "University of New Mexico Children's Hospital", 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}, {'zip': '14203', 'city': 'Buffalo', 'state': 'New York', 'country': 'United States', 'facility': "University of Buffalo, Oishei Children's Hospital", 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}, {'zip': '14642', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': "University of Rochester Medical Center, Golisano Children's Hospital", 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '27705', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Medical Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '27157', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Wake Forest Baptist Medical Center', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': "Rainbow Babies and Children's Hospital, University Hospitals Cleveland Medical Center", 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '44109', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'MetroHealth System, Case CTSA', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': "Oregon Health and Science University, Doernbecher Children's Hospital", 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '19134', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': "Drexel University, St. Christopher's Hospital for Children", 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '29425', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': "Medical University of South Carolina Children's Hospital", 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas - Health Science Center San Antonio', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '84113', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': "Primary Children's Medical Center- University of Utah", 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}], 'overallOfficials': [{'name': 'Daniel Benjamin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke Clinical Research Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}, {'name': 'Johns Hopkins University', 'class': 'OTHER'}, {'name': 'Intermountain Health Care, Inc.', 'class': 'OTHER'}, {'name': 'Vanderbilt University Medical Center', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}