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

NCT07009366 | Completed

• 1 other identifier: DRRABIAZUK
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Respiratory Distress Syndrome, Newborn

Outcome Measures

Primary Outcomes (1)

• Successful weaning

  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.

  4 days

Secondary Outcomes (2)

• Comparison of total days on NCPAP

  4 days

• Hospital stay

  25 days

Study Arms (3)

Sudden weaning of NCPAP

EXPERIMENTAL

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: Sudden weaning of NCPAP

Gradual Weaning with increasing the time off NCPAP

EXPERIMENTAL

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: Gradual weaning with increasing the time off NCPAP

Pressure weaning of NCPAP

EXPERIMENTAL

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.

Procedure: Pressure weaning of NCPAP

Interventions

Sudden weaning of NCPAP PROCEDURE

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.

Sudden weaning of NCPAP

Gradual weaning with increasing the time off NCPAP PROCEDURE

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.

Gradual Weaning with increasing the time off NCPAP

Pressure weaning of NCPAP PROCEDURE

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.

Pressure weaning of NCPAP

Eligibility Criteria

• Age: 1 Hour - 24 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• RESnTEC, Institute of Research: lead

Study Sites (1)

Ziauddin University

Karachi, Sindh, 75600, Pakistan

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome, Newborn

Condition Hierarchy (Ancestors)

Respiratory Distress Syndrome; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Rabia Asif

  Ziauddin University Karachi

  PRINCIPAL INVESTIGATOR

• Heena Rais, FCPS

  Ziauddin University Karachi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2025
• First Posted: June 6, 2025
• Study Start: July 1, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: June 6, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)