NCT06082674

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Ilocos Training and Regional Medical Center · Other Government
• Sex: All
• Age: 5 Minutes – 6 Hours
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Premature
• Respiratory Distress Syndrome in Premature Infant

Interventions

Type	Name	Description
DEVICE	Vayu bCPAP	The Vayu bCPAP uses a constant flow of dry oxygen from the source with an adjustable flow meter. Oxygen is blended by Venturi blender with ambient air to create a source of oxygen-enriched air of adjustable concentration.
DEVICE	Mechanical Ventilator Driven CPAP	Mechanical Ventilator Driven CPAP

Timeline

• Start date: 2022-04-01
• Primary completion: 2022-11-15
• Completion: 2022-12-01
• First posted: 2023-10-13
• Last updated: 2023-10-13

Locations

1 site across 1 country: Philippines