Comparison of Methods of Weaning From Nasal CPAP in Preterm Infants: A Randomized Controlled Trial

Not Applicable

Completed

• Conditions: Respiratory Distress Syndrome, Newborn

• Registration Number: NCT07009366
• Lead Sponsor: RESnTEC, Institute of Research

Brief Summary

This study aimed to determine the efficacy of different NCPAP weaning strategies in pre-term infants presenting with respiratory distress, and ultimately establishing the best method to withdraw from NCPAP.

Detailed Description

Pakistan, as well as other developing countries, lacks data regarding the weaning protocol of NCPAP. Ascertaining the best weaning method that could facilitate a shorter duration on nasal CPAP and the least length of hospital stay is very much needed. Findings of this study would help clinicians to achieve better outcomes for the patients receiving nasal CPAP.

Study Timeline

• Study Start: 2024-07-01
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31
• Status Verified: 2025-05
• Study First Submitted: 2025-05-29
• Study First Submitted QC: 2025-05-29
• Last Update Submitted: 2025-05-29
• Study First Posted: 2025-06-06
• Last Update Posted: 2025-06-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

• Preterm infants
• Any gender
• Low birth weight
• Gestational ages between 28 to below 37 weeks
• Presented with respiratory distress
• Neonates with radiological findings suggestive of respiratory distress, congenital pneumonia/sepsis, or transient tachypnea of the newborn (TTN)

Exclusion Criteria

• Complex congenital abnormalities like diaphragmatic hernia, CNS malformations, intrapartum-related hypoxia, or congenital heart disease.
• Intraventricular hemorrhage grade III or IV or low APGAR scores (<4 or 5 at 5 minutes)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Successful weaning	4 days	Weaning was considered as successful in the absence of pronounced retractions, tachypnea, or episodes of apnea and if there was no requirement for ventilator support after cessation of NCPAP support.

Secondary Outcome Measures

Name	Time	Method
Hospital stay	25 days	Total days of hospital stay were measured from the admission to discharge from the hospital.
Comparison of total days on NCPAP	4 days	Total days on NCPAP for the three weaning strategies were measured from the start of NCPAP to the removal of NCPAP

Trial Locations

Locations (1)

Ziauddin University; 🇵🇰 Karachi, Sindh, Pakistan