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Immediate Treatment Outcomes of Bubble-cpap Versus Oxygen Therapy in Preterm Babies Presenting With Respiratory Distress Syndrome at Kilimanjaro Christian Medical Center
Bubble - Continuous positive airway pressure (CPAP) has been reported to be effective, cheaper, simpler and more accessible compared to mechanical ventilator and surfactant treatment for preterms with respiratory distress syndrome in the neighbouring countries. This study aims to implement and determine the effectiveness of bCPAP and its immediate outcomes compared to oxygen therapy in preterm babies presenting with respiratory distress syndrome (RDS).
Effective treatment of preterm babies with RDS requires exogenous surfactant and/or mechanical ventilation but these are of limited availability in developing countries. bCPAP is generated by exhalation against a constant opening pressure that produces positive end-expiratory pressure. This in-turn helps in maintaining lung volume at the end of expiration, preventing atelectasis, improving oxygenation, reducing respiratory fatigue and eventually preventing respiratory failure. bCPAP (Rice 360◦c low cost bCPAP device) consisting of 3 components: : (i)An air compressor connected to an oxygen concentrator with a gas flow fate of 3-4 L/min; (ii) A nasal interface (short nasal prongs) connecting the baby's airway to a two limb circuit i.e the inspiratory limb connected to the bCPAP machine and the expiratory limb connected to the water bottle and; (iii) An expiratory limb with the distal end submerged 6 cm in water to generate an end expiratory pressure At the neonatal unit at Kilimanjaro Christian Medical Center (KCMC), the standard of care for Preterm babies with RDS is receiving oxygen therapy via nasal prongs from oxygen cylinders.
Age
0 - 0 years
Sex
ALL
Healthy Volunteers
No
Start Date
December 15, 2016
Primary Completion Date
May 15, 2017
Completion Date
May 15, 2017
Last Updated
August 8, 2018
48
ACTUAL participants
bCPAP Arm
DEVICE
Oxygen Arm
OTHER
Lead Sponsor
Kilimanjaro Christian Medical Centre, Tanzania
NCT04016246
NCT05446389
Data Source & Attribution
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View ClinicalTrials.gov Terms and ConditionsNCT04689386