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Recruiting 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

No phase Interventional Respiratory Distress Syndrome (Neonatal)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: HFOV weaning protocol 1, HFOV weaning protocol 2.
Who it may be relevant to
Registry conditions: Respiratory Distress Syndrome (Neonatal). Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Other HFOV weaning protocol 1
    weaning preterm neonates with RDS from HFOV directly to CPAP
  • Other HFOV weaning protocol 2
    weaning of preterm neonates with RDS to CMV then to CPAP

Primary outcome measures

  • comparing weaning failure rate between 2 groups [Time frame: 72 hours after weaning]

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:
  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Mansoura University Children Hospital — Al Mansurah

Identifiers

NCT: NCT07202299 · MD.25.05.1000

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗