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

NCT06082674 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2023-10-13

No results posted yet for this study

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.

Conditions

  • Premature
  • Respiratory Distress Syndrome in Premature Infant

Interventions

DEVICE

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.

DEVICE

Mechanical Ventilator Driven CPAP

Mechanical Ventilator Driven CPAP

Sponsors & Collaborators

  • Ilocos Training and Regional Medical Center

    lead OTHER_GOV

Principal Investigators

  • Navid Roodaki, MD · Ilocos Training and Regional Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
5 Minutes
Max Age
6 Hours
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-01
Primary Completion
2022-11-15
Completion
2022-12-01

Countries

  • Philippines

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06082674 on ClinicalTrials.gov