Status:
COMPLETED
Novel Low Cost Bubble CPAP as an Alternative Respiratory Support in Low Resource Setting
Lead Sponsor:
Ilocos Training and Regional Medical Center
Conditions:
Premature
Respiratory Distress Syndrome in Premature Infant
Eligibility:
All Genders
5-6 years
Phase:
PHASE2
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 ventilat...
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 s...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2022
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT06082674
Start Date
April 1 2022
End Date
December 1 2022
Last Update
October 13 2023
Active Locations (1)
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1
Ilocos Training and Regional Medical Center
San Fernando City, La Union, Philippines, 2500