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NCT Number: 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

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.

Recruiting

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Key information

Conditions

Respiratory Distress Syndrome (Neonatal) Lung Diseases Pulmonary Atelectasis Respiratory Tract Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mansoura University Children Hospital

Al Mansurah, Egypt

Location status: Recruiting

Location contact

Basma O Shouman

CONTACT

[email protected]

+201001550144

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • 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.

Exclusion criteria

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

Treatment and study plan

HFOV weaning protocol 1

Other

weaning preterm neonates with RDS from HFOV directly to CPAP

HFOV weaning protocol 2

Other

weaning of preterm neonates with RDS to CMV then to CPAP

Primary outcomes

  1. comparing weaning failure rate between 2 groups

    Time frame: 72 hours after weaning

    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:

    • Severe hypercapnia (PaCO2 > 60 mmHg) .
    • Hypoxemia ( PaO2 < 50 mm Hg).
    • 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:

    • Titration of CPAP level out of the assigned range (CPAP pressure > 8 cmH2O).
    • Escalation to an alternate mode of non-invasive respiratoy support such as non-invasive positive pressure ventilation (NIPPV).

Study contacts

Contact information is provided by the study sponsor or research team.

Yasmina E Keshta

CONTACT

[email protected]

+201010166023

Sponsors and collaborators

Lead sponsor

Mansoura University Children Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Oct 1, 2025
Registry last updated
Oct 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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