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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vayu CPAP Group | Experimental | The patients will be hooked to VAYu bCPAP |
|
| Mechanical Ventilator Driven CPAP | Active Comparator | Patients will be hooked to Mechanical Ventilator Driven CPAP |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vayu bCPAP | Device | 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. |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| CPAP Failure | Difference in the number of CPAP failure | 8 months |
| surfactant use | total number of surfactant use | 8 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Navid Roodaki, MD | Ilocos Training and Regional Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ilocos Training and Regional Medical Center | San Fernando City | La Union | 2500 | Philippines |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40458453 | Derived | 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. |
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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The study Blinded the investigator and outcome assesors
| Mechanical Ventilator Driven CPAP | Device | Mechanical Ventilator Driven CPAP |
|
| D000091642 | Urogenital Diseases |