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

Ilocos Training and Regional Medical Center

Status and phase

Completed

Phase 2

Conditions

Respiratory Distress Syndrome in Premature Infant

Premature

Treatments

Device: Mechanical Ventilator Driven CPAP

Device: Vayu bCPAP

Study type

Interventional

Funder types

Other

Identifiers

NCT06082674

ITRMC-REC-2022-11

Details and patient eligibility

About

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.

Full 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.

Enrollment

70 patients

Sex

All

Ages

5 minutes to 6 hours old

Volunteers

No Healthy Volunteers

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.