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Completed

NCT Number: NCT07009366

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.

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Key information

Conditions

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

Age range

1 hour–24 hour

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ziauddin University

Karachi, Sindh, 75600, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

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.

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.

Primary outcomes

  1. Successful weaning

    Time frame: 4 days

    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.

Secondary outcomes

  1. Comparison of total days on NCPAP

    Time frame: 4 days

    Total days on NCPAP for the three weaning strategies were measured from the start of NCPAP to the removal of NCPAP

  2. Hospital stay

    Time frame: 25 days

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

Sponsors and collaborators

Lead sponsor

RESnTEC, Institute of Research

Other

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jun 6, 2025
Registry last updated
Jun 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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