Ignite Creation Date:
2025-12-25 @ 3:56 AM
Ignite Modification Date:
2025-12-26 @ 2:46 AM
Study NCT ID:
NCT07148102
Status:
COMPLETED
Last Update Posted:
2025-08-29
First Post:
2025-08-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Diaphragmatic Ultrasound and Thoracic Fluid Content for Prediction of Non-Invasive Ventilation Failure in Neonates
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'C566881', 'term': 'Respiratory Distress Syndrome In Premature Infants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2023-05-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-22', 'studyFirstSubmitDate': '2025-08-22', 'studyFirstSubmitQcDate': '2025-08-22', 'lastUpdatePostDateStruct': {'date': '2025-08-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-08-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2023-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The predictive value', 'timeFrame': 'Two years', 'description': 'The predictive value of DTF, DE, and TFC for NIV failure in preterm neonates with RDS.'}], 'secondaryOutcomes': [{'measure': 'Success Rate', 'timeFrame': 'Two years', 'description': 'Comparing success rates among CPAP, NIPPV, and NHFOV groups,'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['EC', 'NIV', 'RDS', 'TFC', 'DTF', 'DE'], 'conditions': ['Diaphragm Ultrasound', 'Electrical Cardiometry', 'Non Invasive Ventilation (NIV)', 'RDS of Prematurity']}, 'referencesModule': {'references': [{'pmid': '41364345', 'type': 'DERIVED', 'citation': 'Elgendy EM, Elmahdy HS, Nassar MAE, Zidan LK, Eltomey MA, Elsharkawy HM. Diaphragmatic ultrasound and thoracic fluid content for prediction of non-invasive ventilation failure in neonates: a randomized controlled trial. Eur J Pediatr. 2025 Dec 9;185(1):3. doi: 10.1007/s00431-025-06605-8.'}]}, 'descriptionModule': {'briefSummary': 'This research assessed diaphragmatic ultrasound and thoracic fluid content (TFC) as potential early predictive tools for detecting NIV failure in preterm neonates.', 'detailedDescription': 'Non-invasive ventilatory support (NIV) is considered a gold standard care for preterm infants with respiratory distress syndrome (RDS); however, NIV failure remains a frequent challenge that is often associated with many adverse outcomes'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '30 Minutes', 'minimumAge': '30 Minutes', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Preterm neonates (28-34 weeks GA) with RDS and requiring NIV', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Preterm neonates of both sexes, with gestational ages ranging from 28 to 34 weeks, diagnosed with RDS and requiring non-invasive ventilation within 30 minutes of birth\n\nExclusion Criteria:\n\n* Exclusion criteria included intubation in the delivery room, complex congenital heart disease, major congenital anomalies in the lungs or airways, and other causes of respiratory distress unrelated to RDS.'}, 'identificationModule': {'nctId': 'NCT07148102', 'briefTitle': 'Diaphragmatic Ultrasound and Thoracic Fluid Content for Prediction of Non-Invasive Ventilation Failure in Neonates', 'organization': {'class': 'OTHER', 'fullName': 'Tanta University'}, 'officialTitle': 'Diaphragmatic Ultrasound and Thoracic Fluid Content for Prediction of Non-Invasive Ventilation Failure in Neonates', 'orgStudyIdInfo': {'id': 'DTF, DE, TFC with NIV failure'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'CPAP', 'description': '30 infants supported by nasal CPAP', 'interventionNames': ['Device: Diaphragmatic US', 'Device: EC']}, {'label': 'NIPPV', 'description': '30 infants supported by non-invasive positive pressure ventilation', 'interventionNames': ['Device: Diaphragmatic US', 'Device: EC']}, {'label': 'NHFOV', 'description': '30 infants supported with nasal high-frequency oscillatory ventilation', 'interventionNames': ['Device: Diaphragmatic US', 'Device: EC']}], 'interventions': [{'name': 'Diaphragmatic US', 'type': 'DEVICE', 'description': 'Diaphragmatic thickening fraction (DTF) and diaphragmatic excursion (DE) were measured by ultrasound within the first three hours of life and repeated either 24 hours later in successful cases or immediately before intubation in cases who had NIV failure.', 'armGroupLabels': ['CPAP', 'NHFOV', 'NIPPV']}, {'name': 'EC', 'type': 'DEVICE', 'description': 'TFC was assessed using electrical cardiometry (EC). Measurements were obtained within the first three hours of life and repeated either 24 hours later in successful cases or immediately before intubation in cases who had NIV failure.', 'armGroupLabels': ['CPAP', 'NHFOV', 'NIPPV']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31527', 'city': 'Tanta', 'state': 'Tanta, Q2x2+cp Tanta 2, Egypt', 'country': 'Egypt', 'facility': 'Faculty of Medicine, Tanta University', 'geoPoint': {'lat': 30.78847, 'lon': 31.00192}}], 'overallOfficials': [{'name': 'Heba Saied Elmahdy, Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Faculty of Medicine, Tanta University, Tanta, Q2x2+cp Tanta 2, Egypt, 31527'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lamiaa Khaled Zidan', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Lecturer of Pediatrics', 'investigatorFullName': 'Lamiaa Khaled Zidan', 'investigatorAffiliation': 'Tanta University'}}}}