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

Premature Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06082674
• Other study ID #: ITRMC-REC-2022-11
• Status: Completed
• Phase: Phase 2
• Start date: April 1, 2022
• Est. completion date: December 1, 2022

Study information

• Verified date: October 2023
• Source: Ilocos Training and Regional Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: December 1, 2022
• Est. primary completion date: November 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Minutes to 6 Hours

Eligibility

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.

Related Conditions & MeSH terms

• Premature
• Premature Birth
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome in Premature Infant
• Respiratory Distress Syndrome, Newborn
• Syndrome

Intervention

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.
• Mechanical Ventilator Driven CPAP
Mechanical Ventilator Driven CPAP

Locations

Country	Name	City	State
Philippines	Ilocos Training and Regional Medical Center	San Fernando	La Union

Sponsors (1)

Lead Sponsor	Collaborator
Ilocos Training and Regional Medical Center

Country where clinical trial is conducted

Philippines, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Oxygen Saturation	Difference in the oxygen saturation using pulse oximeter	8 months
Secondary	CPAP Failure	Difference in the number of CPAP failure	8 months
Secondary	surfactant use	total number of surfactant use	8 months