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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

RecruitingNAAges any - anyAllMansoura University Children Hospital
NCT07202299 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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: 1. Severe hypercapnea PaCO2 \> 60 mmHg associated with pH \< 7.25. 2. Hypoxemia PaO2 \< 50 mmHg, with FiO2 \> 40%. 3. 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: Preterm infants with any of the following : 1. Major congenital malformations or chromosomal aberrations. 2. Inborn errors of metabolism. 3. Severe intraventricular hemorrhage (IVH) grade III or IV
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What it tests

  • HFOV weaning protocol 1
  • HFOV weaning protocol 2
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Where

1 site
Mansoura University Children Hospital
Al Mansurah, Egypt
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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