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

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

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.

Study Overview

• Status: Completed
• Conditions: Premature; Respiratory Distress Syndrome in Premature Infant
• Intervention / Treatment: Device: Vayu bCPAP; Device: Mechanical Ventilator Driven CPAP

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.

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Phase 2

Contacts and Locations

Study Locations

• Philippines
  • La Union
    • San Fernando, La Union, Philippines, 2500
      • Ilocos Training and Regional Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Vayu CPAP Group; The patients will be hooked to VAYu bCPAP	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.
Active Comparator: Mechanical Ventilator Driven CPAP; Patients will be hooked to Mechanical Ventilator Driven CPAP	Device: Mechanical Ventilator Driven CPAP; Mechanical Ventilator Driven CPAP

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Ilocos Training and Regional Medical Center
• Investigators: Principal Investigator: Navid Roodaki, MD, Ilocos Training and Regional Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2022
• Primary Completion (Actual): November 15, 2022
• Study Completion (Actual): December 1, 2022

Study Registration Dates

• First Submitted: October 3, 2023
• First Submitted That Met QC Criteria: October 7, 2023
• First Posted (Actual): October 13, 2023

Study Record Updates

• Last Update Posted (Actual): October 13, 2023
• Last Update Submitted That Met QC Criteria: October 7, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Disease; Infant, Newborn, Diseases; Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Infant, Premature, Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Syndrome; Premature Birth; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn
• Other Study ID Numbers: ITRMC-REC-2022-11

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No