Ignite Creation Date:
2025-12-24 @ 9:32 PM
Ignite Modification Date:
2026-02-13 @ 3:52 PM
Study NCT ID:
NCT02587832
Status:
COMPLETED
Last Update Posted:
2015-10-27
First Post:
2015-10-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
High Flow Nasal Cannula in Comparison With Nasal Continuous Positive Airway Pressure in the Management of Respiratory Distress Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012128', 'term': 'Respiratory Distress Syndrome'}, {'id': 'C564247', 'term': 'Microcephaly, Primary Autosomal Recessive, 6'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012120', 'term': 'Respiration Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-10-25', 'studyFirstSubmitDate': '2015-10-20', 'studyFirstSubmitQcDate': '2015-10-25', 'lastUpdatePostDateStruct': {'date': '2015-10-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-10-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the need for re-intubation', 'timeFrame': '5 DAYS', 'description': 'The primary outcome measured was failed extubation defined by the need for re-intubation and mechanical ventilation within five days of initial extubation.'}], 'secondaryOutcomes': [{'measure': 'Duration of respiratory support using HHHFNC /NCPAP.', 'timeFrame': 'through study completion, an average of 1 year.'}, {'measure': 'Incidence of nasal breakdown', 'timeFrame': 'through study completion, an average of 24 weeks'}, {'measure': 'sepsis', 'timeFrame': 'through study completion, an average of 1 year.'}, {'measure': 'intraventricular hemorrhage (IVH),', 'timeFrame': 'through study completion, an average of 24 weeks'}, {'measure': 'retinopathy of prematurity (ROP)', 'timeFrame': 'through study completion, an average of 24 weeks', 'description': 'number of participants with sepsis will be compared between the two arms. Sepsis was defined as a positive culture result from blood with concomitant clinical symptoms. Positive cultures were defined as having positive growth from the cerebrospinal fluid, tracheal, blood, or urine specimens.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['cpap', 'HHHFNC', 'RDS', 'ELBW'], 'conditions': ['Respiratory Distress Syndrome']}, 'descriptionModule': {'briefSummary': 'To compare the primary outcome, failure of extubation defined by the need for re-intubation and mechanical ventilation within 5 days of initial extubation and secondary outcomes, morbidities and mortality after using of heated humidity high flow nasal cannula (HHHFNC) and Nasal Continuous Positive Airway Pressure (NCPAP) in the immediate post-extubation period for preterm infants between 24 and 28 weeks gestation with respiratory distress syndrome.', 'detailedDescription': 'Inclusion criteria were: 1) Preterm neonates with gestational age of 24 to 28 completed weeks. 2) In the case of twins, both neonates were included in the same treatment arm. 3) Success to wean with 24 hours to extubate. 4) Parental written informed consent for participation in the study obtained on admission into the hospital or prior to delivery.\n\nExclusion criteria were: 1) Evidence of severe birth asphyxia. 2) Known genetic or chromosomal disorders. 3) Infants delivered to mothers with ruptured membranes of more than three weeks duration. 4) Potentially life-threatening conditions unrelated to prematurity. 5) Participation in another clinical trial of any placebo, drug, biological, or device conducted under the provisions of a protocol.\n\nRandomization A computer-generated block-randomization sequence with random block sizes was used. Infants who were part of multiple births underwent individual randomization. Clinicians opened consecutively numbered, sealed, brown envelopes immediately before extubation to determine the study-group assignment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Preterm neonates with gestational age of 24 to 28 completed weeks.\n2. In the case of twins, both neonates were included in the same treatment arm.\n3. Success to wean with 24 hours to extubate.\n4. Parental written informed consent for participation in the study obtained on admission into the hospital or prior to delivery.\n\nExclusion Criteria:\n\n1. Evidence of severe birth asphyxia.\n2. Known genetic or chromosomal disorders.\n3. Infants delivered to mothers with ruptured membranes of more than three weeks duration.\n4. Potentially life-threatening conditions unrelated to prematurity.\n5. Participation in another clinical trial of any placebo, drug, biological, or device conducted under the provisions of a protocol.'}, 'identificationModule': {'nctId': 'NCT02587832', 'briefTitle': 'High Flow Nasal Cannula in Comparison With Nasal Continuous Positive Airway Pressure in the Management of Respiratory Distress Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Sidra Medicine'}, 'officialTitle': 'Randomized Control Trial: Heated Humidity High Flow Nasal Cannula in Comparison With Nasal Continuous Positive Airway Pressure in the Management of Respiratory Distress Syndrome in Extreme Low Birth Infants in Immediate Post Extubation Period', 'orgStudyIdInfo': {'id': '081110'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'HHHFNC', 'description': 'Randomized to HHHFNC', 'interventionNames': ['Device: HHHFNC']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'NCPAP', 'description': 'Randomized to NCPAP', 'interventionNames': ['Device: NCPAP']}], 'interventions': [{'name': 'HHHFNC', 'type': 'DEVICE', 'otherNames': ['VAPOTHERM'], 'description': 'Tri-Anim Vaptherm the Precision Flow, which is a self contained unit that provides flow rates up to or 8 LPM (Infants) of blended oxygen that is heated and humidified', 'armGroupLabels': ['HHHFNC']}, {'name': 'NCPAP', 'type': 'DEVICE', 'description': 'Bubble CPAP System.', 'armGroupLabels': ['NCPAP']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44308', 'city': 'Akron', 'state': 'Ohio', 'country': 'United States', 'facility': "Akron Children's Hospital", 'geoPoint': {'lat': 41.08144, 'lon': -81.51901}}], 'overallOfficials': [{'name': 'Mohammed Elkhwad, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Akron Children's Hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sidra Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': "Akron Children's Hospital", 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Mohammed Elkhwad', 'investigatorAffiliation': "Akron Children's Hospital"}}}}