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

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.

Study Overview

• Status: Completed
• Conditions: Respiratory Distress Syndrome, Newborn
• Intervention / Treatment: Procedure: Sudden weaning of NCPAP; Procedure: Gradual weaning with increasing the time off NCPAP; Procedure: Pressure weaning of 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 Type: Interventional
• Enrollment (Actual): 75
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Sindh
    • Karachi, Sindh, Pakistan, 75600
      • Ziauddin University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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: 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.
Experimental: 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: 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.
Experimental: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: RESnTEC, Institute of Research
• Investigators: Principal Investigator: Rabia Asif, Ziauddin University Karachi; Study Director: Heena Rais, FCPS, Ziauddin University Karachi

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2024
• Primary Completion (Actual): December 31, 2024
• Study Completion (Actual): December 31, 2024

Study Registration Dates

• First Submitted: May 29, 2025
• First Submitted That Met QC Criteria: May 29, 2025
• First Posted (Actual): June 6, 2025

Study Record Updates

• Last Update Posted (Actual): June 6, 2025
• Last Update Submitted That Met QC Criteria: May 29, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Respiration Disorders; Infant, Premature, Diseases; Infant, Newborn, Diseases; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn
• Other Study ID Numbers: DRRABIAZUK

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data can be shared on a reasonable request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No