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

Randomized Controlled Trial of Two Protocols for Weaning From High Frequency Oscillatory Ventilation in Preterm Neonates With Respiratory Distress Syndrome

This trial tests two different methods to stop high-frequency oscillatory ventilation in preterm infants with respiratory distress syndrome to see which leads to fewer complications.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 110 (estimated)
• Sex: All
• Sponsor: Mansoura University Children Hospital (other)
• Locations: 1 site (Al Mansurah)
• Trial ID: NCT07202299 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Preterm infants (gestational age ≤34 weeks) with respiratory distress syndrome who required HFOV for more than 24 hours after failing noninvasive respiratory support are eligible.

Not a fit: Infants with major congenital malformations, chromosomal abnormalities, inborn errors of metabolism, or severe intraventricular hemorrhage (grade III/IV) are excluded and would not be expected to benefit from the trial protocol results.

Why it matters

Potential benefit: If successful, the preferred protocol could shorten time on HFOV and reduce complications for preterm infants with respiratory distress syndrome.

How similar studies have performed: There are limited randomized trials comparing HFOV weaning protocols and some observational reports support protocolized weaning, but high-quality evidence is still sparse.

Eligibility criteria

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 this trial is running

Al Mansurah

• Mansoura University Children Hospital — Al Mansurah, Egypt (RECRUITING)

Study contacts

• Study coordinator: Yasmina E Keshta

Conditions: Respiratory Distress Syndrome