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

RESnTEC, Institute of Research

Status: Completed

Conditions: Respiratory Distress Syndrome, Newborn

Treatments: Procedure: Pressure weaning of NCPAP; Procedure: Gradual weaning with increasing the time off NCPAP; Procedure: Sudden weaning of NCPAP

Study type: Interventional

Funder types: Other

Identifiers

NCT07009366

DRRABIAZUK

Details and patient eligibility

About

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.

Full 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.

Enrollment: 75 patients

Sex: All

Ages: 1 to 24 hours old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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75 participants in 3 patient groups

Sudden weaning of NCPAP

Experimental group

Description:

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.

Treatment:

Procedure: Sudden weaning of NCPAP

Gradual Weaning with increasing the time off NCPAP

Experimental group

Description:

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.

Treatment:

Procedure: Gradual weaning with increasing the time off NCPAP

Pressure weaning of NCPAP

Experimental group

Description:

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.

Treatment:

Procedure: Pressure weaning of NCPAP