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

NCT ID: NCT07009366

Last Updated: 2025-06-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-01
• Study Completion Date: 2024-12-31

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.

Conditions

Respiratory Distress Syndrome, Newborn

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Sudden weaning of NCPAP

Intervention Type: 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.

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.

Group Type: EXPERIMENTAL

Gradual weaning with increasing the time off NCPAP

Intervention Type: 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.

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.

Group Type: EXPERIMENTAL

Pressure weaning of NCPAP

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility Criteria

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)

• Minimum Eligible Age: 1 Hour
• Maximum Eligible Age: 24 Hours
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

RESnTEC, Institute of Research

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rabia Asif

Role: PRINCIPAL_INVESTIGATOR

Ziauddin University Karachi

Heena Rais, FCPS

Role: STUDY_DIRECTOR

Ziauddin University Karachi

Locations

Ziauddin University

Karachi, Sindh, Pakistan

Countries

Pakistan

Other Identifiers

DRRABIAZUK

Identifier Type: -

Identifier Source: org_study_id