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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 | Clinical Trials | Clareo Health

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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

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

NCT07202299•Mansoura University Children Hospital

View on ClinicalTrials.gov

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

Age

All ages

Sex

ALL

Healthy Volunteers

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

Locations (1)

Mansoura University Children Hospital

Al Mansurah, Egypt

Key Dates

Start Date

September 22, 2025

Primary Completion Date

March 1, 2027

Completion Date

September 1, 2027

Last Updated

October 1, 2025

Enrollment

110

ESTIMATED participants

Conditions

Respiratory Distress Syndrome (Neonatal)

Interventions

HFOV weaning protocol 1

OTHER

HFOV weaning protocol 2

OTHER

Contacts

Yasmina E Keshta

CONTACT

+201010166023 yasminakeshta@mans.edu.eg

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 1, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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