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
Randomized Controlled Trial of Two Protocols for Weaning From High Frequency Oscillatory Ventilation in Preterm Neonates With Respiratory Distress Syndrome
Mansoura University Children Hospital
110 participants
Sep 22, 2025
INTERVENTIONAL
Conditions
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 order to establish the best weaning strategy with the least complications possible for this group of patients.
Eligibility
Inclusion Criteria4
- 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 Criteria4
- 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
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Interventions
weaning preterm neonates with RDS from HFOV directly to CPAP
weaning of preterm neonates with RDS to CMV then to CPAP
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07202299