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

Phase 2

Completed

• Conditions: Premature; Respiratory Distress Syndrome in Premature Infant
• Interventions: Device: Mechanical Ventilator Driven CPAP; Device: Vayu bCPAP

• Registration Number: NCT06082674
• Lead Sponsor: Ilocos Training and Regional Medical Center

Brief 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.

Study Timeline

• Study Start: 2022-04-01
• Primary Completion: 2022-11-15
• Study Completion: 2022-12-01
• Status Verified: 2023-10
• Study First Submitted: 2023-10-03
• Study First Submitted QC: 2023-10-07
• Last Update Submitted: 2023-10-07
• Study First Posted: 2023-10-13
• Last Update Posted: 2023-10-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• Included are preterm neonates less than 36 weeks (WHO definition)
• admitted at NICU
• APGAR scores of > 7 in the 1st and 5th minute of life
• in respiratory distress at birth,
• radiologic findings of RDS
• Respiratory Severity Score (RSS) or Downe's score > 4 at 10-15 minutes after hooking to CPAP
• requiring CPAP or more than 40% FiO2

Exclusion Criteria

• Infants requiring neonatal resuscitation such as bag mask ventilation, chest compression or intubation at birth
• with comorbidities such as facial anomalies, tracheoesophageal fistulas, congenital heart disease, and other congenital anomalies which may interfere with the interface of both devices.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mechanical Ventilator Driven CPAP	Mechanical Ventilator Driven CPAP	Patients will be hooked to Mechanical Ventilator Driven CPAP
Vayu CPAP Group	Vayu bCPAP	The patients will be hooked to VAYu bCPAP

Primary Outcome Measures

Name	Time	Method
Partial pressure of carbon dioxide (pC02) using Arterial Blood Gas	8 months	Difference in the Partial pressure of carbon dioxide (pC02) using Arterial Blood Gas
Oxygen Saturation	8 months	Difference in the oxygen saturation using pulse oximeter
Partial pressure of arterial oxygen (pa02) using Arterial Blood Gas	8 months	Difference in the Partial pressure of arterial oxygen (pa02) using Arterial Blood Gas

Secondary Outcome Measures

Name	Time	Method
CPAP Failure	8 months	Difference in the number of CPAP failure
surfactant use	8 months	total number of surfactant use

Trial Locations

Locations (1)

Ilocos Training and Regional Medical Center; 🇵🇭 San Fernando, La Union, Philippines