RecruitingNot Applicable

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

Egypt110 participantsStarted 2025-09-22

Plain-language 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.

Who can participate

SexALL

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Inclusion criteria

✓. 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 criteria

✕. Major congenital malformations or chromosomal aberrations.
✕. Inborn errors of metabolism.
✕. Severe intraventricular hemorrhage (IVH) grade III or IV

What they're measuring

comparing weaning failure rate between 2 groups

Timeframe: 72 hours after weaning

Trial details

NCT IDNCT07202299

SponsorMansoura University Children Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-03

Contact for this trial

Yasmina E Keshta

+201010166023 yasminakeshta@mans.edu.eg

View on ClinicalTrials.gov More Respiratory Distress Syndrome (Neonatal) trials