About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Major congenital malformations or chromosomal aberrations.
Inborn errors of metabolism.
Severe intraventricular hemorrhage (IVH) grade III or IV
Trial design
Parallel
Treatments tested in this trial
HFOV weaning protocol 1
Other interventionweaning preterm neonates with RDS from HFOV directly to CPAP
HFOV weaning protocol 2
Other interventionweaning of preterm neonates with RDS to CMV then to CPAP
Treatment groups
Trial outcomes
Primary outcomes
comparing weaning failure rate between 2 groups
Failure of weaning will be considered if the infant develops respiratory distress again requiring re-intubation within 72 hours after extubation due to any of the following: 1. Severe hypercapnia (PaCO2 \> 60 mmHg) . 2. Hypoxemia ( PaO2 \< 50 mm Hg). 3. Frequent apnea (6 apnea episodes within 6-hour period or 1 apneic episode requiring bag and mask positive pressure ventilation). Or escalation of respiratory support as following: 4. Titration of CPAP level out of the assigned range (CPAP pressure \> 8 cmH2O). 5. Escalation to an alternate mode of non-invasive respiratoy support such as non-invasive positive pressure ventilation (NIPPV).
Sponsors and contacts
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