NCT06082674

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Apr 2022

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2022

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

October 3, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 13, 2023

Completed
Last Updated

October 13, 2023

Status Verified

October 1, 2023

Enrollment Period

8 months

First QC Date

October 3, 2023

Last Update Submit

October 7, 2023

Conditions

PrematureRespiratory Distress Syndrome in Premature Infant

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (2)

  • CPAP Failure

    8 months

  • surfactant use

    8 months

Study Arms (2)

Vayu CPAP Group

EXPERIMENTAL

The patients will be hooked to VAYu bCPAP

Device: Vayu bCPAP

Mechanical Ventilator Driven CPAP

ACTIVE COMPARATOR

Patients will be hooked to Mechanical Ventilator Driven CPAP

Device: Mechanical Ventilator Driven CPAP

Interventions

Vayu bCPAPDEVICE

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.

Vayu CPAP Group
Mechanical Ventilator Driven CPAPDEVICE

Mechanical Ventilator Driven CPAP

Mechanical Ventilator Driven CPAP

Eligibility Criteria

Age5 Minutes - 6 Hours
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ilocos Training and Regional Medical Center

San Fernando City, La Union, 2500, Philippines

Location

Related Publications (1)

  • Badin S, Roodaki N, Garcia DEC, Abila-Cariaga R, Burke TF. Evaluation of a novel reprocessed bCPAP system on sepsis rates among preterm neonates with respiratory distress: a randomized controlled trial. Front Pediatr. 2025 May 19;13:1569437. doi: 10.3389/fped.2025.1569437. eCollection 2025.

    PMID: 40458453DERIVED

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Navid Roodaki, MD

    Ilocos Training and Regional Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
The study Blinded the investigator and outcome assesors
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

October 3, 2023

First Posted

October 13, 2023

Study Start

April 1, 2022

Primary Completion

November 15, 2022

Study Completion

December 1, 2022

Last Updated

October 13, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

PH(1)