Ignite Creation Date:
2025-12-24 @ 11:54 PM
Ignite Modification Date:
2025-12-25 @ 9:49 PM
Study NCT ID:
NCT07241351
Status:
COMPLETED
Last Update Posted:
2025-12-02
First Post:
2025-11-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Dexmedetomidine as an Adjunct to Fentanyl for Term Neonates on Mechanical Ventilation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000377', 'term': 'Agnosia'}], 'ancestors': [{'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020927', 'term': 'Dexmedetomidine'}, {'id': 'D005283', 'term': 'Fentanyl'}], 'ancestors': [{'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D010880', 'term': 'Piperidines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2025-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-25', 'studyFirstSubmitDate': '2025-11-17', 'studyFirstSubmitQcDate': '2025-11-17', 'lastUpdatePostDateStruct': {'date': '2025-12-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-11-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'need for additional rescue analgesia', 'timeFrame': '24 hours', 'description': 'number of doses of rescue analgesia given during the first 24 hours'}, {'measure': 'NPASS ( neonatal pain , agitation and sedation score)', 'timeFrame': '24 hours', 'description': 'done hourly to indicate pain and sedation if more than or equal to three patient is in pain'}], 'secondaryOutcomes': [{'measure': 'development of bradycardia,', 'timeFrame': '24 hours', 'description': 'development of bradycardia,'}, {'measure': 'development of hypotension', 'timeFrame': '24 hours', 'description': 'development of hypotension'}, {'measure': 'development of respiratory depression', 'timeFrame': '24 hours', 'description': 'development of respiratory depression'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['sedation', 'analgesia', 'full term neonates', 'dexmedetomidine', 'fentanyl', 'adjuvant'], 'conditions': ['Analgesia', 'Sedation and Analgesia', 'Neonatal', 'Mechanical Ventilation in Neonates']}, 'descriptionModule': {'briefSummary': 'Despite well conducted studies on pain management in mechanically ventilated neonates, there is still a need for exploration of appropriate and accurate pharmacological management strategies for this ongoing pain, and assessment of the clinical impact of the used drugs for analgesia and sedation.\n\nIn the current study, the aim was to reduce fentanyl doses on mechanical ventilated neonates after adding Dexmedetomidine', 'detailedDescription': 'Despite well conducted studies on pain management in mechanically ventilated neonates, there is still a need for exploration of appropriate and accurate pharmacological management strategies for this ongoing pain, and assessment of the clinical impact of the used drugs for analgesia and sedation. Opioids, such as fentanyl, are frequently used for analgesia and sedation in mechanically ventilated neonates with their short- and long-term adverse consequences Dexmedetomidine (DEX) is a specific alpha2 adrenergic agonist with promising data in NICU. Data exist that Dexmedetomidine recipient neonates require less adjunct sedation, experience less respiratory depression, less clinically significant hemodynamic effects, quicker establishment of enteral feeds and they could be extubated whilst on Dexmedetomidine infusion.\n\nIn the current study, the aim was to reduce fentanyl doses on mechanical ventilated neonates after adding Dexmedetomidine'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '28 Days', 'minimumAge': '1 Hour', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Full term neonates (≥ 37 weeks gestational age)\n* Age: 1 to 28 days.\n* Neonates just started invasive mechanical ventilation and are going to start sedation.\n\nExclusion Criteria:\n\n* Presence of central nervous system abnormality\n* Complex multiple congenital anomalies\n* Neonates with facial malformations\n* Neonates on mechanical Ventilation setting (peep above 9)'}, 'identificationModule': {'nctId': 'NCT07241351', 'briefTitle': 'Dexmedetomidine as an Adjunct to Fentanyl for Term Neonates on Mechanical Ventilation', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Dexmedetomidine as an Adjunct to Fentanyl for Analgesia and Sedation of Term Neonates on Mechanical Ventilation', 'orgStudyIdInfo': {'id': 'Dexmedetomidine as an Adjunct'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'dexmedetomidine and fentanyl', 'description': 'fentanyl as a continuous infusion dose of 0.5 mcg/kg/hr over 24 hours with concomitant administration of DEX continuous IV infusion, over 24 hours, at a maintenance dose of 0.3 mcg/kg/hr for neonates \\<14 days and 0.5 mcg/kg/hr for those ≥14 days postnatal age', 'interventionNames': ['Drug: Dexmedetomidine', 'Drug: fentanyl 0.5 mcg/kg/hr']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'fentanyl only', 'description': 'fentanyl as continuous infusion at 1.0 mcg/kg/hr over 24', 'interventionNames': ['Drug: fentanyl 1mcg/kg/hr']}], 'interventions': [{'name': 'Dexmedetomidine', 'type': 'DRUG', 'description': 'administration of DEX continuous IV infusion, over 24 hours, at a maintenance dose of 0.3 mcg/kg/hr for neonates \\<14 days and 0.5 mcg/kg/hr for those ≥14 days postnatal age', 'armGroupLabels': ['dexmedetomidine and fentanyl']}, {'name': 'fentanyl 1mcg/kg/hr', 'type': 'DRUG', 'description': 'fentanyl as continuous infusion at 1.0 mcg/kg/hr over 24 hours', 'armGroupLabels': ['fentanyl only']}, {'name': 'fentanyl 0.5 mcg/kg/hr', 'type': 'DRUG', 'description': 'fentanyl as a continuous infusion dose of 0.5 mcg/kg/hr over 24 hours with concomitant', 'armGroupLabels': ['dexmedetomidine and fentanyl']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'Ain Shams University Hospitals', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'mariam JA ibrahim, PHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ain Shams University'}, {'name': 'Rouzan A Nassar, MBBCH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'MOHP Egypt'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'ipdSharing': 'YES', 'description': 'data can be shared from the corresponding author upon reasonable request'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'assistant professor', 'investigatorFullName': 'Mariam Ibrahim', 'investigatorAffiliation': 'Ain Shams University'}}}}