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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: f
View:

• 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:

‣ 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.

Locations
Other Locations
Egypt
Mansoura University Children Hospital
RECRUITING
Al Mansurah
Contact Information
Primary
Yasmina E Keshta
yasminakeshta@mans.edu.eg
+201010166023
Time Frame
Start Date: 2025-09-22
Estimated Completion Date: 2027-09
Participants
Target number of participants: 110
Treatments
Experimental: Group 1 (intervention group)
Group I (Intervention group): Fifty five preterm infants with direct weaning from HFOV (high frequency oscillatory ventilation) to CPAP (continuous positive airway pressure).
Active_comparator: Group II (Control group)
Group II (Control group): Fifty five preterm infants with weaning from HFOV (high frequency oscillatory ventilation) to conventional mechanical ventilation (CMV) then to CPAP (continuous positive airway pressure) .
Related Therapeutic Areas
Sponsors
Leads: Mansoura University Children Hospital

This content was sourced from clinicaltrials.gov