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

Phase 2

Completed

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.

Recruitment & Eligibility

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.

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

Locations (1): Ilocos Training and Regional Medical Center
🇵🇭
San Fernando, La Union, Philippines
Ilocos Training and Regional Medical Center
🇵🇭San Fernando, La Union, Philippines