Novel Low Cost Bubble CPAP as an Alternative Respiratory Support in Low Resource Setting

Premature Clinical Trial

Official title: Novel Low Cost Bubble CPAP as an Alternative Non-invasive Respiratory Support Among Preterm Infants With Respiratory Distress Syndrome

Status Completed

Clinical Trial Summary

This is a single-blind randomized controlled trial done in a Level III neonatal intensive care unit. Preterm newborns with RDS were randomized to receive oxygen therapy through bubble CPAP vs ventilator-derived CPAP. Differences in arterial blood gases, oxygen saturation, number of surfactant and CPAP failure rate between study groups were analyzed.

Clinical Trial Description

Background and Objective: Respiratory distress syndrome (RDS) among premature infants is one of the major causes of neonatal death. The use of continuous positive airway pressure (CPAP) has become a standard of care for preterm newborns with RDS. In countries faced with the challenge of improving neonatal care, cost-effective innovations for respiratory support are a promising intervention. This study determined the efficacy of a low-cost bubble CPAP as an alternative non-invasive oxygen therapy for newborn infants with RDS.

METHODS: This is a single-blind randomized controlled trial done in a Level III neonatal intensive care unit. Preterm newborns with RDS were randomized to receive oxygen therapy through bubble CPAP vs ventilator-derived CPAP. Differences in arterial blood gases, oxygen saturation, number of surfactant and CPAP failure rate between study groups were analyzed. ;

Related Conditions & MeSH terms

• Premature
• Premature Birth
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome in Premature Infant
• Respiratory Distress Syndrome, Newborn
• Syndrome

• NCT number: NCT06082674
• Study type: Interventional
• Source: Ilocos Training and Regional Medical Center
• Status: Completed
• Phase: Phase 2
• Start date: April 1, 2022
• Completion date: December 1, 2022