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

NCT07009366 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2025-06-06

No results posted yet for this study

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.

Conditions

  • Respiratory Distress Syndrome, Newborn

Interventions

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.

Sponsors & Collaborators

  • RESnTEC, Institute of Research

    lead OTHER

Principal Investigators

  • Rabia Asif · Ziauddin University Karachi

  • Heena Rais, FCPS · Ziauddin University Karachi

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Hour
Max Age
24 Hours
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-01
Primary Completion
2024-12-31
Completion
2024-12-31

Countries

  • Pakistan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07009366 on ClinicalTrials.gov