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

NCT07202299 | Recruiting

• 1 other identifier: MD.25.05.1000
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Respiratory Distress Syndrome (Neonatal)

Outcome Measures

Primary Outcomes (1)

• 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).

  72 hours after weaning

Study Arms (2)

Group 1 (intervention group)

EXPERIMENTAL

Group I (Intervention group): Fifty five preterm infants with direct weaning from HFOV (high frequency oscillatory ventilation) to CPAP (continuous positive airway pressure).

Other: HFOV weaning protocol 1

Group II (Control group)

ACTIVE COMPARATOR

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) .

Other: HFOV weaning protocol 2

Interventions

HFOV weaning protocol 1 OTHER

weaning preterm neonates with RDS from HFOV directly to CPAP

Group 1 (intervention group)

HFOV weaning protocol 2 OTHER

weaning of preterm neonates with RDS to CMV then to CPAP

Group II (Control group)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Mansoura University Children Hospital: lead

Study Sites (1)

Mansoura University Children Hospital

Al Mansurah, Egypt

RECRUITING

MeSH Terms

Conditions

Pulmonary Atelectasis

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Yasmina E Keshta

CONTACT

+201010166023; yasminakeshta@mans.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant lecturer of pediatrics

Study Record Dates

• First Submitted: September 23, 2025
• First Posted: October 1, 2025
• Study Start: September 22, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: October 1, 2025

Record last verified: 2025-09

Locations

EG (1)