Diaphragmatic Ultrasound and Thoracic Fluid Content for Prediction of Non-Invasive Ventilation Failure in Neonates
1 other identifier
observational
90
1 country
1
Brief Summary
This research assessed diaphragmatic ultrasound and thoracic fluid content (TFC) as potential early predictive tools for detecting NIV failure in preterm neonates.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started May 2020
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2023
CompletedFirst Submitted
Initial submission to the registry
August 22, 2025
CompletedFirst Posted
Study publicly available on registry
August 29, 2025
CompletedAugust 29, 2025
August 1, 2025
3 years
August 22, 2025
August 22, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The predictive value
The predictive value of DTF, DE, and TFC for NIV failure in preterm neonates with RDS.
Two years
Secondary Outcomes (1)
Success Rate
Two years
Study Arms (3)
CPAP
30 infants supported by nasal CPAP
NIPPV
30 infants supported by non-invasive positive pressure ventilation
NHFOV
30 infants supported with nasal high-frequency oscillatory ventilation
Interventions
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.
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.
Eligibility Criteria
Preterm neonates (28-34 weeks GA) with RDS and requiring NIV
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Faculty of Medicine, Tanta University
Tanta, Tanta, Q2x2+cp Tanta 2, Egypt, 31527, Egypt
Related Publications (1)
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.
PMID: 41364345DERIVED
MeSH Terms
Conditions
Study Officials
- STUDY DIRECTOR
Heba Saied Elmahdy, Professor
Faculty of Medicine, Tanta University, Tanta, Q2x2+cp Tanta 2, Egypt, 31527
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Lecturer of Pediatrics
Study Record Dates
First Submitted
August 22, 2025
First Posted
August 29, 2025
Study Start
May 1, 2020
Primary Completion
May 1, 2023
Study Completion
May 1, 2023
Last Updated
August 29, 2025
Record last verified: 2025-08