Premature, Respiratory Distress Syndrome in Premature Infant
Conditions
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.
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.
Interventions
DEVICEVayu 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.
DEVICEMechanical Ventilator Driven CPAP
Mechanical Ventilator Driven CPAP
Sponsors
Ilocos Training and Regional Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
The study Blinded the investigator and outcome assesors
Eligibility
Sex/Gender
ALL
Age
5 Minutes to 6 Hours
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| CPAP Failure | 8 months | Difference in the number of CPAP failure |
| surfactant use | 8 months | total number of surfactant use |
Countries
Philippines
Outcome results
None listed