Ignite Creation Date:
2025-12-24 @ 10:14 PM
Ignite Modification Date:
2025-12-25 @ 7:48 PM
Study NCT ID:
NCT07113535
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-08
First Post:
2025-07-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Post-extubation Use RAM Cannula Versus Short Binasal Prong Interfaces in Preterm Infants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D047928', 'term': 'Premature Birth'}, {'id': 'D012128', 'term': 'Respiratory Distress Syndrome'}], 'ancestors': [{'id': 'D007752', 'term': 'Obstetric Labor, Premature'}, {'id': 'D007744', 'term': 'Obstetric Labor Complications'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'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': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-08', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-04', 'studyFirstSubmitDate': '2025-07-28', 'studyFirstSubmitQcDate': '2025-08-04', 'lastUpdatePostDateStruct': {'date': '2025-08-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Failure of extubation incidence rate', 'timeFrame': "28 days of an infant's life", 'description': 'Need for reintubation within 72 hours post-extubation trial'}], 'secondaryOutcomes': [{'measure': 'Duration of non-invasive ventilation', 'timeFrame': '120 days', 'description': 'Days on non-invasive ventilation'}, {'measure': 'whole duration of oxygen therapy', 'timeFrame': '120 days', 'description': 'Days on oxygen therapy during NICU admission'}, {'measure': 'Diaphragmatic indices and lung ultrasound scores post-extubation (pre & post extubation then weekly)', 'timeFrame': '120 days', 'description': 'Diaphragmatic indices (diaphragmatic thickness \\&excursion) and lung ultrasound scores post-extubation'}, {'measure': 'Need for reintubation within 7 days', 'timeFrame': "28 days of an infant's life", 'description': 'Need for reintubation within 72 hours post-extubation trial'}, {'measure': 'Bronchopulmonary dysplasia', 'timeFrame': '120 days'}, {'measure': 'Mortality', 'timeFrame': '120 days', 'description': 'Pre-discharge mortality'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['nasal interface', 'noninvasive respiratory support', 'premature', 'RAM cannula', 'Chest ultrasound', 'Diaphragm'], 'conditions': ['Premature', 'Respiratory Distress Syndrome', 'Extubation']}, 'referencesModule': {'references': [{'pmid': '31394948', 'type': 'BACKGROUND', 'citation': 'Gokce IK, Kaya H, Ozdemir R. A randomized trial comparing the short binasal prong to the RAM cannula for noninvasive ventilation support of preterm infants with respiratory distress syndrome. J Matern Fetal Neonatal Med. 2021 Jun;34(12):1868-1874. doi: 10.1080/14767058.2019.1651268. Epub 2019 Aug 8.'}]}, 'descriptionModule': {'briefSummary': 'Nowadays, the use of non-invasive ventilation for preterm infants in the NICU has increased to avoid complications associated with prolonged endotracheal intubation. Adequate pressure delivery through non-invasive ventilation is essential, as it enhances the growth and development of premature lungs. Various interfaces have been used to ensure proper sealing. The RAM cannula, used as an interface for non-invasive respiratory support in preterm neonates, is associated with reduced nasal trauma compared to short binasal prongs (SBPs), due to its softer material, making it a safer option. However, the RAM cannula has been shown to deliver lower pharyngeal pressure and, therefore, may not maintain airway pressure as consistently as nasal prongs. Currently, limited data is available regarding the efficacy of nasal prongs compared to the RAM cannula as a post-extubation interface for non-invasive ventilation support in preterm infants. Additionally, we have observed that the use of the RAM cannula for non-invasive ventilation in preterm infants is associated with a longer duration of oxygen therapy compared to SBPs.\n\nThe investigators hypothesize that the RAM cannula provides a lower level of positive end-expiratory pressure compared to SBPs during non-invasive ventilation.\n\nThe investigators aim to assess the efficacy and safety of the RAM cannula versus SBPs as nasal interfaces for post-extubation non-invasive respiratory support in preterm infants.', 'detailedDescription': 'Preterm infants will be randomized to receive post-extubation non invasive respiratory support either through RAM cannula or SBPs. Neonates in both groups will be uniformly managed as per unit protocol as following:\n\nExtubation criteria :\n\n* Birth weight \\< 1000 gram :MAP \\<7 cmH2O and FIO2 \\<0.30\n* Birth weight\\>1000 gram :MAP \\>8 cmH2O and FIO2 \\<0.30\n\nRe intubation criteria :\n\n* FIO2\\>0.60 to maintain SaO2 \\>88% OR PaO2 \\> 45 mmHg\n* PaCO2 {arterial} \\> 55-60 with PH \\< 7.25\n* Apnea and requiring bag and mask ventilation\n* Evidence of increased work of breathing {retractions -grunting -chest wall distortion } plus abnormal chest x ray'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '28 Days', 'minimumAge': '24 Hours', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Inborn preterm neonates ≤ 32 weeks of gestational and/or birth weight ≤1500 g with respiratory distress syndrome requiring initial invasive ventilation support for at least 24 hours.\n\nExclusion Criteria:\n\n* Outborn preterm neonates\n* Major congenital malformations.'}, 'identificationModule': {'nctId': 'NCT07113535', 'briefTitle': 'Post-extubation Use RAM Cannula Versus Short Binasal Prong Interfaces in Preterm Infants', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Ministry of Health, Saudi Arabia'}, 'officialTitle': 'RAM Cannula Versus Short Binasal Prong Interfaces of Non- Invasive Ventilation for Prevention of Extubating Failure in Preterm Infants: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'H-03-M-11'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'RAM cannula group', 'description': 'Preterm infants will receive non-invasive ventilation by RAM cannula', 'interventionNames': ['Other: RAM cannula']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Short binasal prong group', 'description': 'Preterm infants will receive non-invasive ventilation by short binasal prongs', 'interventionNames': ['Other: Short binasal prong']}], 'interventions': [{'name': 'RAM cannula', 'type': 'OTHER', 'description': 'RAM cannula as an interface for non invasive ventilation in preterm newborns', 'armGroupLabels': ['RAM cannula group']}, {'name': 'Short binasal prong', 'type': 'OTHER', 'description': 'Short binasal prong as an interface for non invasive ventilation in preterm newborns', 'armGroupLabels': ['Short binasal prong group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Madinah', 'country': 'Saudi Arabia', 'facility': 'King Salman Bin Abdulaziz Medical City', 'geoPoint': {'lat': 24.46861, 'lon': 39.61417}}], 'centralContacts': [{'name': 'Ohoud Almoualled, Dr', 'role': 'CONTACT', 'email': 'o.doc2or@gmail.com', 'phone': '+966500550679'}, {'name': 'Nehad Nasef, Dr', 'role': 'CONTACT'}], 'overallOfficials': [{'name': 'Nehad Nasef, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'King Salman Bin Abdulaziz Medical City'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'Data requests can be submitted starting 3 months after article publication and the data will be made accessible for up to 12 months. Extensions will be considered on a case-by-case basis', 'ipdSharing': 'YES', 'description': 'Data obtained through this study may be provided to qualified researchers for research and scientific purposes (i.e conduction of meta-analysis or systematic review). Data or samples shared will be coded, with no protected health information included. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party.', 'accessCriteria': 'Access to raw data (no protected health information) can be requested by qualified researchers for scientific purposes, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA)'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ministry of Health, Saudi Arabia', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Fellow of Neonatal- perinatal medicine, NICU', 'investigatorFullName': 'hussam murayh mohammed ali', 'investigatorAffiliation': 'Ministry of Health, Saudi Arabia'}}}}