NCT07009366

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 75 (actual)
• Sponsor: RESnTEC, Institute of Research · Academic / Other
• Sex: All
• Age: 1 Hour – 24 Hours
• Healthy volunteers: Not accepted

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.

Conditions

• Respiratory Distress Syndrome, Newborn

Interventions

Type	Name	Description
PROCEDURE	Sudden weaning of NCPAP	NCPAP was taken "off" entirely when the neonate met the "stability criteria" and remained on oxygen or room air via a headbox or incubator with an aim to stay off NCPAP.
PROCEDURE	Gradual weaning with increasing the time off NCPAP	The regimen adopted for this method was 1 hour off twice a day on the 1st day, then 2 hours off twice a day on the 2nd day, hence increasing the time off to 6 hours twice a day (or 12 hours per day), i.e., using a smaller period off. At this point, NCPAP was taken off completely.
PROCEDURE	Pressure weaning of NCPAP	In this method the pressure was reduced in steps of 1 cm of H2O every 12 to 24 hours until 5 cm of H2O, and then if the child tolerated it well, NCPAP was removed, and the child was shifted to oxygen via incubator or room air according to the situation.

Timeline

• Start date: 2024-07-01
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2025-06-06
• Last updated: 2025-06-06

Locations

1 site across 1 country: Pakistan