Status:
RECRUITING
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
Lead Sponsor:
Mansoura University Children Hospital
Conditions:
Respiratory Distress Syndrome (Neonatal)
Eligibility:
All Genders
Phase:
NA
Brief Summary
Our study is a randomized controlled trial that compares two weaning protocols of preterm infants with respiratory distress syndrome who are ventilated on high frequency oscillatory ventilation in ord...
Eligibility Criteria
Inclusion
- Preterm infants with RDS whose gestational age is 34 weeks or less who required HFOV for more than 24 hours duration due to failure of non- invasive respiratory support due to any of the following:
- Severe hypercapnea PaCO2 \> 60 mmHg associated with pH \< 7.25.
- Hypoxemia PaO2 \< 50 mmHg, with FiO2 \> 40%.
- Frequent apneas: 6 or more episodes of apnea requiring mild or moderate stimulation within 6-hour period or one apneic episode requiring bag and mask positive pressure ventilation.
Exclusion
- Preterm infants with any of the following :
- Major congenital malformations or chromosomal aberrations.
- Inborn errors of metabolism.
- Severe intraventricular hemorrhage (IVH) grade III or IV
Key Trial Info
Start Date :
September 22 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2027
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT07202299
Start Date
September 22 2025
End Date
September 1 2027
Last Update
October 1 2025
Active Locations (1)
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1
Mansoura University Children Hospital
Al Mansurah, Egypt