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

Recruiting now · Not applicable

Conditions studied: Respiratory Distress Syndrome (Neonatal)

In brief

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.

Key facts

Study ID

NCT07202299

Run by

Mansoura University Children Hospital

People needed

110

Starts

2025-09-22

Expected to finish

2027-09-01

Last updated by the study team

2025-10-01

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Preterm infants with any of the following :
• Major congenital malformations or chromosomal aberrations.
• Inborn errors of metabolism.
• Severe intraventricular hemorrhage (IVH) grade III or IV

Where it is running

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

Full record on ClinicalTrials.gov

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