Comparing two ways to wean preterm babies from high-frequency oscillatory ventilation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an open-label randomized trial enrolling preterm infants (≤34 weeks gestation) with respiratory distress syndrome who have been on high-frequency oscillatory ventilation (HFOV) for more than 24 hours after failure of noninvasive support. Enrolled infants are randomly assigned to one of two predefined HFOV weaning protocols and managed in the NICU at Mansoura University Children Hospital. Outcomes will include measures of successful weaning, duration of mechanical support, and frequency of complications such as apnea, hypoxemia, or need to return to HFOV. The trial aims to identify a practical weaning approach that minimizes ventilation time and adverse events in this population.

Why it matters

Who can join: the full rules

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

Where it's running

• Mansoura University Children Hospital
  Al Mansurah, Egypt Recruiting

Study contacts

• Study coordinator: Yasmina E Keshta
• Email: yasminakeshta@mans.edu.eg
• Phone: +201010166023

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.