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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-01

Study Completion Date

2022-12-01

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.

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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.

Conditions

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Premature Respiratory Distress Syndrome in Premature Infant

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

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Study Groups

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Vayu CPAP Group

The patients will be hooked to VAYu bCPAP

Group Type EXPERIMENTAL

Vayu bCPAP

Intervention Type DEVICE

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.

Mechanical Ventilator Driven CPAP

Patients will be hooked to Mechanical Ventilator Driven CPAP

Group Type ACTIVE_COMPARATOR

Mechanical Ventilator Driven CPAP

Intervention Type DEVICE

Mechanical Ventilator Driven CPAP

Interventions

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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.

Intervention Type DEVICE

Mechanical Ventilator Driven CPAP

Intervention Type DEVICE

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.

Minimum Eligible Age

5 Minutes

Maximum Eligible Age

6 Hours

Eligible Sex

ALL

Accepts Healthy Volunteers

No