NCT07202299 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
| NCT ID | NCT07202299 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Mansoura University Children Hospital |
| Condition | Respiratory Distress Syndrome (Neonatal) |
| Study Type | INTERVENTIONAL |
| Enrollment | 110 participants |
| Start Date | 2025-09-22 |
| Primary Completion | 2027-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 110 participants in total. It began in 2025-09-22 with a primary completion date of 2027-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07202299 clinical trial?
This trial is open to participants of all sexes, studying Respiratory Distress Syndrome (Neonatal). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07202299 currently recruiting?
Yes, NCT07202299 is actively recruiting participants. Contact the research team at yasminakeshta@mans.edu.eg for enrollment information.
Where is the NCT07202299 trial being conducted?
This trial is being conducted at Al Mansurah, Egypt.
Who is sponsoring the NCT07202299 clinical trial?
NCT07202299 is sponsored by Mansoura University Children Hospital. The trial plans to enroll 110 participants.