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

RESnTEC, Institute of Research75 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Respiratory Distress Syndrome, Newborn

Interventions

Sudden weaning of NCPAPPROCEDURE

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 NCPAPPROCEDURE

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 NCPAPPROCEDURE

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.

Eligibility

Sex: ALLMin age: 1 HourMax age: 24 Hours

Medical Language ↔ Plain English

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)

Locations (1)

Ziauddin University

Karachi, Sindh, Pakistan

Outcomes

Primary Outcomes

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.

Time frame: 4 days

Secondary Outcomes

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

Time frame: 4 days

Hospital stay

Total days of hospital stay were measured from the admission to discharge from the hospital.

Time frame: 25 days

Data from ClinicalTrials.gov

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