Ignite Creation Date:
2025-12-24 @ 4:25 PM
Ignite Modification Date:
2026-01-04 @ 11:52 PM
Study NCT ID:
NCT07009366
Status:
COMPLETED
Last Update Posted:
2025-06-06
First Post:
2025-05-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Methods of Weaning From Nasal CPAP in Preterm Infants: A Randomized Controlled Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012127', 'term': 'Respiratory Distress Syndrome, Newborn'}], 'ancestors': [{'id': 'D012128', 'term': 'Respiratory Distress Syndrome'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D007235', 'term': 'Infant, Premature, Diseases'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 75}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-29', 'studyFirstSubmitDate': '2025-05-29', 'studyFirstSubmitQcDate': '2025-05-29', 'lastUpdatePostDateStruct': {'date': '2025-06-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Successful weaning', 'timeFrame': '4 days', 'description': 'Weaning was considered as successful in the absence of pronounced retractions, tachypnea, or episodes of apnea and if there was no requirement for ventilator support after cessation of NCPAP support.'}], 'secondaryOutcomes': [{'measure': 'Comparison of total days on NCPAP', 'timeFrame': '4 days', 'description': 'Total days on NCPAP for the three weaning strategies were measured from the start of NCPAP to the removal of NCPAP'}, {'measure': 'Hospital stay', 'timeFrame': '25 days', 'description': 'Total days of hospital stay were measured from the admission to discharge from the hospital.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Respiratory Distress Syndrome, Newborn']}, 'descriptionModule': {'briefSummary': 'This study aimed to determine the efficacy of different NCPAP weaning strategies in pre-term infants presenting with respiratory distress, and ultimately establishing the best method to withdraw from NCPAP.', 'detailedDescription': 'Pakistan, as well as other developing countries, lacks data regarding the weaning protocol of NCPAP. Ascertaining the best weaning method that could facilitate a shorter duration on nasal CPAP and the least length of hospital stay is very much needed. Findings of this study would help clinicians to achieve better outcomes for the patients receiving nasal CPAP.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '24 Hours', 'minimumAge': '1 Hour', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Preterm infants\n* Any gender\n* Low birth weight\n* Gestational ages between 28 to below 37 weeks\n* Presented with respiratory distress\n* Neonates with radiological findings suggestive of respiratory distress, congenital pneumonia/sepsis, or transient tachypnea of the newborn (TTN)\n\nExclusion Criteria:\n\n* Complex congenital abnormalities like diaphragmatic hernia, CNS malformations, intrapartum-related hypoxia, or congenital heart disease.\n* Intraventricular hemorrhage grade III or IV or low APGAR scores (\\<4 or 5 at 5 minutes)'}, 'identificationModule': {'nctId': 'NCT07009366', 'briefTitle': 'Comparison of Methods of Weaning From Nasal CPAP in Preterm Infants: A Randomized Controlled Trial', 'organization': {'class': 'OTHER', 'fullName': 'RESnTEC, Institute of Research'}, 'officialTitle': 'Comparison of Methods of Weaning From Nasal CPAP in Preterm Infants: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'DRRABIAZUK'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sudden weaning of NCPAP', 'description': 'NCPAP was taken "off" entirely when the neonate met the "stability criteria" and remained on oxygen or room air via a headbox or incubator with an aim to stay off NCPAP.', 'interventionNames': ['Procedure: Sudden weaning of NCPAP']}, {'type': 'EXPERIMENTAL', 'label': 'Gradual Weaning with increasing the time off NCPAP', 'description': 'The regimen adopted for this method was 1 hour off twice a day on the 1st day, then 2 hours off twice a day on the 2nd day, hence increasing the time off to 6 hours twice a day (or 12 hours per day), i.e., using a smaller period off. At this point, NCPAP was taken off completely.', 'interventionNames': ['Procedure: Gradual weaning with increasing the time off NCPAP']}, {'type': 'EXPERIMENTAL', 'label': 'Pressure weaning of NCPAP', 'description': 'In this method the pressure was reduced in steps of 1 cm of H2O every 12 to 24 hours until 5 cm of H2O, and then if the child tolerated it well, NCPAP was removed, and the child was shifted to oxygen via incubator or room air according to the situation.', 'interventionNames': ['Procedure: Pressure weaning of NCPAP']}], 'interventions': [{'name': 'Sudden weaning of NCPAP', 'type': 'PROCEDURE', 'description': 'NCPAP was taken "off" entirely when the neonate met the "stability criteria" and remained on oxygen or room air via a headbox or incubator with an aim to stay off NCPAP.', 'armGroupLabels': ['Sudden weaning of NCPAP']}, {'name': 'Gradual weaning with increasing the time off NCPAP', 'type': 'PROCEDURE', 'description': 'The regimen adopted for this method was 1 hour off twice a day on the 1st day, then 2 hours off twice a day on the 2nd day, hence increasing the time off to 6 hours twice a day (or 12 hours per day), i.e., using a smaller period off. At this point, NCPAP was taken off completely.', 'armGroupLabels': ['Gradual Weaning with increasing the time off NCPAP']}, {'name': 'Pressure weaning of NCPAP', 'type': 'PROCEDURE', 'description': 'In this method the pressure was reduced in steps of 1 cm of H2O every 12 to 24 hours until 5 cm of H2O, and then if the child tolerated it well, NCPAP was removed, and the child was shifted to oxygen via incubator or room air according to the situation.', 'armGroupLabels': ['Pressure weaning of NCPAP']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75600', 'city': 'Karachi', 'state': 'Sindh', 'country': 'Pakistan', 'facility': 'Ziauddin University', 'geoPoint': {'lat': 24.8608, 'lon': 67.0104}}], 'overallOfficials': [{'name': 'Rabia Asif', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ziauddin University Karachi'}, {'name': 'Heena Rais, FCPS', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ziauddin University Karachi'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Data can be shared on a reasonable request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'RESnTEC, Institute of Research', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}