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

Primary Purpose

Premature, Respiratory Distress Syndrome in Premature Infant

Status
Completed
Phase
Phase 2
Locations
Philippines
Study Type
Interventional
Intervention
Vayu bCPAP
Mechanical Ventilator Driven CPAP
Sponsored by
Ilocos Training and Regional Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Premature

Eligibility Criteria

5 Minutes - 6 Hours (Child)All SexesDoes not accept 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.

Sites / Locations

  • Ilocos Training and Regional Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Vayu CPAP Group

Mechanical Ventilator Driven CPAP

Arm Description

The patients will be hooked to VAYu bCPAP

Patients will be hooked to Mechanical Ventilator Driven CPAP

Outcomes

Primary Outcome Measures

Partial pressure of arterial oxygen (pa02) using Arterial Blood Gas
Difference in the Partial pressure of arterial oxygen (pa02) using Arterial Blood Gas
Partial pressure of carbon dioxide (pC02) using Arterial Blood Gas
Difference in the Partial pressure of carbon dioxide (pC02) using Arterial Blood Gas
Oxygen Saturation
Difference in the oxygen saturation using pulse oximeter

Secondary Outcome Measures

CPAP Failure
Difference in the number of CPAP failure
surfactant use
total number of surfactant use

Full Information

First Posted
October 3, 2023
Last Updated
October 7, 2023
Sponsor
Ilocos Training and Regional Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT06082674
Brief Title
Novel Low Cost Bubble CPAP as an Alternative Respiratory Support in Low Resource Setting
Official Title
Novel Low Cost Bubble CPAP as an Alternative Non-invasive Respiratory Support Among Preterm Infants With Respiratory Distress Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
April 1, 2022 (Actual)
Primary Completion Date
November 15, 2022 (Actual)
Study Completion Date
December 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ilocos Training and Regional Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premature, Respiratory Distress Syndrome in Premature Infant

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Masking Description
The study Blinded the investigator and outcome assesors
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vayu CPAP Group
Arm Type
Experimental
Arm Description
The patients will be hooked to VAYu bCPAP
Arm Title
Mechanical Ventilator Driven CPAP
Arm Type
Active Comparator
Arm Description
Patients will be hooked to Mechanical Ventilator Driven CPAP
Intervention Type
Device
Intervention Name(s)
Vayu bCPAP
Intervention Description
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
Intervention Name(s)
Mechanical Ventilator Driven CPAP
Intervention Description
Mechanical Ventilator Driven CPAP
Primary Outcome Measure Information:
Title
Partial pressure of arterial oxygen (pa02) using Arterial Blood Gas
Description
Difference in the Partial pressure of arterial oxygen (pa02) using Arterial Blood Gas
Time Frame
8 months
Title
Partial pressure of carbon dioxide (pC02) using Arterial Blood Gas
Description
Difference in the Partial pressure of carbon dioxide (pC02) using Arterial Blood Gas
Time Frame
8 months
Title
Oxygen Saturation
Description
Difference in the oxygen saturation using pulse oximeter
Time Frame
8 months
Secondary Outcome Measure Information:
Title
CPAP Failure
Description
Difference in the number of CPAP failure
Time Frame
8 months
Title
surfactant use
Description
total number of surfactant use
Time Frame
8 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Minutes
Maximum Age & Unit of Time
6 Hours
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Navid Roodaki, MD
Organizational Affiliation
Ilocos Training and Regional Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ilocos Training and Regional Medical Center
City
San Fernando
State/Province
La Union
ZIP/Postal Code
2500
Country
Philippines

12. IPD Sharing Statement

Plan to Share IPD
No

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

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