Novel Low Cost Bubble CPAP as an Alternative Respiratory Support in Low Resource Setting
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
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 Design
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures
- Partial pressure of arterial oxygen (pa02) using Arterial Blood Gas [8 months]
Difference in the Partial pressure of arterial oxygen (pa02) using Arterial Blood Gas
- Partial pressure of carbon dioxide (pC02) using Arterial Blood Gas [8 months]
Difference in the Partial pressure of carbon dioxide (pC02) using Arterial Blood Gas
- Oxygen Saturation [8 months]
Difference in the oxygen saturation using pulse oximeter
Secondary Outcome Measures
- CPAP Failure [8 months]
Difference in the number of CPAP failure
- surfactant use [8 months]
total number of surfactant use
Eligibility Criteria
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
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in respiratory distress at birth,
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radiologic findings of RDS
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Respiratory Severity Score (RSS) or Downe's score > 4 at 10-15 minutes after hooking to CPAP
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requiring CPAP or more than 40% FiO2
Exclusion Criteria:
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Infants requiring neonatal resuscitation such as bag mask ventilation, chest compression or intubation at birth
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with comorbidities such as facial anomalies, tracheoesophageal fistulas, congenital heart disease, and other congenital anomalies which may interfere with the interface of both devices.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Ilocos Training and Regional Medical Center | San Fernando | La Union | Philippines | 2500 |
Sponsors and Collaborators
- Ilocos Training and Regional Medical Center
Investigators
- Principal Investigator: Navid Roodaki, MD, Ilocos Training and Regional Medical Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ITRMC-REC-2022-11