Clinical trial NCT06082674: Novel Low Cost Bubble CPAP as an Alternative Respiratory Support in Low Resource Setting
Official title: Novel Low Cost Bubble CPAP as an Alternative Non-invasive Respiratory Support Among Preterm Infants With Respiratory Distress Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Premature
Respiratory Distress Syndrome in Premature Infant
Lead sponsor: Ilocos Training and Regional Medical Center
Sponsor class: OTHER_GOV
First posted: 2023-10-13
Enrollment: 70
Sex: ALL
Minimum age (years): 5
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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
* 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.

Primary outcomes:
measure: Partial pressure of arterial oxygen (pa02) using Arterial Blood Gas
timeFrame: 8 months
measure: Partial pressure of carbon dioxide (pC02) using Arterial Blood Gas
timeFrame: 8 months
measure: Oxygen Saturation
timeFrame: 8 months
Secondary outcomes:
measure: CPAP Failure
timeFrame: 8 months
measure: surfactant use
timeFrame: 8 months
Other outcomes:
Locations:
city: San Fernando
country: Philippines
facility: Ilocos Training and Regional Medical Center
state: La Union
Study officials:
affiliation: Ilocos Training and Regional Medical Center
name: Navid Roodaki, MD
role: PRINCIPAL_INVESTIGATOR
References: