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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Premature, Respiratory Distress Syndrome in Premature Infant

Intervention / Treatment
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* Device: Vayu bCPAP
* Device: Mechanical Ventilator Driven CPAP


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 5 Minutes
Maximum Age: 6 Hours

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vayu CPAP Group<br>The patients will be hooked to VAYu bCPAP | Device: Vayu bCPAP<br>* 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.<br>|
| Active Comparator: Mechanical Ventilator Driven CPAP<br>Patients will be hooked to Mechanical Ventilator Driven CPAP | Device: Mechanical Ventilator Driven CPAP<br>* Mechanical Ventilator Driven CPAP<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Partial pressure of arterial oxygen (pa02) using Arterial Blood Gas | Difference in the Partial pressure of arterial oxygen (pa02) using Arterial Blood Gas | 8 months | 
| Partial pressure of carbon dioxide (pC02) using Arterial Blood Gas | Difference in the Partial pressure of carbon dioxide (pC02) using Arterial Blood Gas | 8 months | 
| Oxygen Saturation | Difference in the oxygen saturation using pulse oximeter | 8 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CPAP Failure | Difference in the number of CPAP failure | 8 months | 
| surfactant use | total number of surfactant use | 8 months |