Ignite Creation Date:
2025-12-25 @ 12:02 AM
Ignite Modification Date:
2026-02-24 @ 5:45 AM
Study NCT ID:
NCT02996058
Status:
COMPLETED
Last Update Posted:
2018-07-03
First Post:
2016-12-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety And Efficacy Of Dexmedetomidine Sedation In Intubated Mechanically Ventilated Infants With Respiratory Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D020927', 'term': 'Dexmedetomidine'}], 'ancestors': [{'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2018-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-01', 'studyFirstSubmitDate': '2016-12-15', 'studyFirstSubmitQcDate': '2016-12-16', 'lastUpdatePostDateStruct': {'date': '2018-07-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-12-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'University of Michigan sedation scale', 'timeFrame': '72H', 'description': 'The university of Michigan sedation scale (UMSS) will be assessed every hour'}], 'secondaryOutcomes': [{'measure': 'The blood pressure', 'timeFrame': '72h', 'description': 'The invasive arterial blood pressure will be recorded every hour'}, {'measure': 'The heart rate', 'timeFrame': '72h', 'description': 'The heart rate will be recorded every hour.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Sedation']}, 'descriptionModule': {'briefSummary': 'Dexmedetomidine is a highly selective α2-agonist with hypnotic, analgesic, and anxiolytic properties. Despite off-label administration, dexmedetomidine has found a niche in critically ill mechanically ventilated neonates and infants because of its minimal effects on respiratory function at sedative doses, facilitating early extubation and fast-track postoperative care.', 'detailedDescription': 'Critically ill children require sedation for comfort and to facilitate mechanical ventilation and interventions. The ideal sedative agent for use in critically ill children has to be effective and short-acting, of rapid onset of action, lacks active metabolites, does not accumulate in patients with renal or hepatic dysfunction, has minimal to no cardiovascular or respiratory adverse effects, and has few drug interactions.\n\nDexmedetomidine is a highly selective α2-agonist with hypnotic, analgesic, and anxiolytic properties. Despite off-label administration, dexmedetomidine has found a niche in critically ill mechanically ventilated neonates and infants because of its minimal effects on respiratory function at sedative doses, facilitating early extubation and fast-track postoperative care.\n\nThe only FDA approved indication of dexmedetomidine is sedation of intubated mechanically ventilated adults for less than 24h. However, the literature is full of many research studies that investigated the use off-lable use of dexmedetomidine for sedation more than 24h in both adult and pediatric population and proved its safety and effectiveness.\n\nThe aim of this study will be to investigate the safety and efficacy of dexmedetomidine in two different doses in sedation for critically ill mechanically ventilated infants with respiratory failure for 72h duration.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Months', 'minimumAge': '1 Month', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Infants (1-12 months).\n* Respiratory failure/\n* Requiring PICU admission and mechanical ventilation up to 72h.\n\nExclusion Criteria:\n\n* Significant renal, hepatic, endocrine or metabolic disease.\n* 2nd or 3rd degree heart block.\n* hypotension or bradycardia (defined as any value outside the normal range from the patient's age)."}, 'identificationModule': {'nctId': 'NCT02996058', 'acronym': 'DEXinPICU', 'briefTitle': 'Safety And Efficacy Of Dexmedetomidine Sedation In Intubated Mechanically Ventilated Infants With Respiratory Failure', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Dexmedetomidine Sedation in Pediatric Intensive Care Unit', 'orgStudyIdInfo': {'id': 'IRB00008718/00436'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'DEX I 0.35µg/kg /h', 'description': 'the infants will receive a maintenance dose of 0.35µg/kg /h of Dexmedetomidne without a loading dose and guided by the assessed sedation scale', 'interventionNames': ['Drug: Dexmedetomidine 0.35µg/kg /h']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'DEX II 0.5µg/kg /h', 'description': 'the infants will receive a maintenance dose of 0.5µg/kg /h of Dexmedetomidne without a loading dose and guided by the assessed sedation scale.', 'interventionNames': ['Drug: Dexmedetomidine 0.5µg/kg /h']}], 'interventions': [{'name': 'Dexmedetomidine 0.35µg/kg /h', 'type': 'DRUG', 'otherNames': ['Precedex'], 'description': 'the infants will receive a maintenance dose of 0.35µg/kg /h of Dexmedetomidne without a loading dose and guided by the assessed sedation scale', 'armGroupLabels': ['DEX I 0.35µg/kg /h']}, {'name': 'Dexmedetomidine 0.5µg/kg /h', 'type': 'DRUG', 'otherNames': ['Precedex'], 'description': 'the infants will receive a maintenance dose of 0.5µg/kg /h of Dexmedetomidne without a loading dose and guided by the assessed sedation scale', 'armGroupLabels': ['DEX II 0.5µg/kg /h']}]}, 'contactsLocationsModule': {'locations': [{'zip': '715715', 'city': 'Asyut', 'state': 'Assiut Governorate', 'country': 'Egypt', 'facility': 'Pediatric hospital', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}], 'overallOfficials': [{'name': 'Hala S Abdel-Ghaffar, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assisstant professor in anesthesia and intensive care, faculty of medicine, Assiut university, Egypt'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assisstant professor in anesthesia and intensive care, Faculty of medicine, Assiut university, Egypt.', 'investigatorFullName': 'Hala Saad Abdel-Ghaffar', 'investigatorAffiliation': 'Assiut University'}}}}