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Not Yet Recruiting NCT07837141

Noninvasive High Frequency Oscillatory Ventilation Versus Nasal Intermittent Mandatory Ventilation for Respiratory Distress Syndrome in Preterm Neonates

Conditions: Respiratory Distress Syndrome (RDS), Newborn, Premature Birth

Sex: All
Ages: 0 Hours – 6 Hours
Healthy volunteers: No
Phase: NA
Enrollment: 158
Sponsor: Aga Khan University

Location: Aga Khan University Hospital, Karachi Stadium Road, P.O.Box 3500 Karachi 74800, Pakistan Karachi Sindh

Summary

The goal of this clinical trial is to learn if nasal high frequency oscillatory ventilation (nHFOV) works no worse than nasal intermittent mandatory ventilation (NIMV) as early breathing support. The study will include preterm babies born from 28 weeks through 36 weeks of gestation..All babies will have respiratory distress syndrome and need noninvasive breathing support within six hours of birth. Noninvasive support helps breathing through a nasal interface without placing a tube in the windpipe. The main questions it aims to answer are: Does nHFOV work no worse than NIMV in preventing the need for a breathing tube within 72 hours? What medical problems occur in babies receiving each type of breathing support? Researchers will compare nHFOV with NIMV. nHFOV uses rapid, small pressure waves. NIMV provides regular supported breaths. Both methods are routinely used at the study hospital. Babies will: Be assigned by chance to receive either nHFOV or NIMV Receive regular monitoring of breathing, oxygen levels, and medical condition Be assessed for the need for a breathing tube during the first 72 hours Be followed for complications of disease and assigned treatment during hospitalization and after discharge when required The study will also record breathing support duration, hospital stay, survival, chronic lung disease, severe bleeding in the brain, and eye disease related to prematurity. The findings may help doctors choose breathing support for preterm babies with respiratory distress syndrome.

Eligibility Criteria

Inclusion Criteria: * Preterm neonates born between 28+0 and 36+0 weeks of gestation, whether inborn or outborn * Gestational age confirmed by first-trimester ultrasound, last menstrual period, or Ballard score * Clinical and radiological evidence of respiratory distress syndrome * Requirement for NIMV-level noninvasive respiratory support according to the protocol-defined criteria * Enrollment and randomization within 6 hours after birth * Written informed consent provided by a parent or legal guardian Exclusion Criteria: * Intubation and receipt of invasive mechanical ventilation at the time of enrollment * Receipt of surfactant before randomization by any method, including INSURE, LISA, MIST, or surfactant administration before transfer to Aga Khan University Hospital * Major congenital anomaly affecting respiratory or cardiovascular physiology

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07837141). StuddyBuddy aggregates publicly available trial information.