bCPAP Arm
DevicebCPAP (Rice 360◦c low cost bCPAP device)
NCT Number: NCT03620448
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).
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Notify Me28 week–37 week
All sexes
Interventional
Not applicable
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
bCPAP (Rice 360◦c low cost bCPAP device)
Oxygen therapy from oxygen cylinders
Time frame: 6 months
The proportion of babies discharged alive in the bCPAP arm versus the oxygen therapy arm.
Time frame: 6 months
The time spent on the allocated treatment arm till RDS symptoms (tachypnea (>60breaths/min), intercostal and subcostal recessions, nasal flaring, grunting and cyanosis) resolve.
Time frame: 6 months
Time from admission into the neonatal ward to discharge (dead or alive).
Time frame: 6 months
Whilst the subject is receiving treatment, the following complications will be observed and recorded; like pneumothorax, nasal bleeding, injury to the skin, nose or eye, aspiration pneumonia, vomiting and any other complication considered related to the treatment as per the principal investigator's clinical judgement.
Kilimanjaro Christian Medical Centre, Tanzania
Other
Immediate Treatment Outcomes of Bubble-cpap Versus Oxygen Therapy in Preterm Babies Presenting With Respiratory Distress Syndrome at Kilimanjaro Christian Medical Center
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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