Actively Recruiting
Randomized Controlled Trial Comparing Two Weaning Protocols From High Frequency Oscillatory Ventilation in Preterm Neonates With Respiratory Distress Syndrome
Led by Mansoura University Children Hospital · Updated on 2025-10-01
110
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to compare two different protocols for weaning preterm infants with respiratory distress syndrome (RDS) who are on high frequency oscillatory ventilation (HFOV). The goal is to find the best weaning strategy that results in the fewest complications for these vulnerable newborns. The study is a randomized controlled trial conducted at Mansoura University Children Hospital and focuses on infants born at 34 weeks gestation or earlier. Participants are randomly assigned to one of two groups. The first group is weaned directly from HFOV to continuous positive airway pressure (CPAP). The second group is weaned from HFOV to conventional mechanical ventilation (CMV) before moving to CPAP. Each group includes 55 preterm infants, and the trial compares the outcomes of these two weaning methods. During the study, researchers monitor the infants closely to measure the rate of weaning failure within 72 hours after weaning. This involves observing respiratory status and any complications during this critical period. The study does not use blinding. The total participation duration and additional assessments are not specified, but the primary focus is on the immediate success of the weaning protocols.
CONDITIONS
Brief Title
Open-label Randomized Controlled Trial of Two Protocols for Weaning From High Frequency Oscillatory Ventilation in Preterm Neonates With Respiratory Distress Syndrome Admitted in the NICU of Mansoura University Children Hospital
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Preterm infants with respiratory distress syndrome born at 34 weeks gestation or less
- Required high frequency oscillatory ventilation for more than 24 hours due to failure of non-invasive respiratory support
- Severe hypercapnea with PaCO2 greater than 60 mmHg and pH less than 7.25
- Hypoxemia with PaO2 less than 50 mmHg and FiO2 greater than 40%
- Frequent apneas defined as 6 or more episodes requiring stimulation within 6 hours or one episode requiring positive pressure ventilation
You will not qualify if you...
- Major congenital malformations or chromosomal abnormalities
- Inborn errors of metabolism
- Severe intraventricular hemorrhage grade III or IV
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Until successful weaning or up to 72 hours after weaning
Participants receive one of two weaning protocols from high frequency oscillatory ventilation (HFOV) to continuous positive airway pressure (CPAP), either directly or through conventional mechanical ventilation (CMV).
Daily visits during weaning period
Trial Site Locations
Total: 1 location
1
Mansoura University Children Hospital
Al Mansurah, Egypt
Actively Recruiting
Research Team
Y
Yasmina E Keshta
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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