Treatment outcomes of Pumani bubble-CPAP versus oxygen therapy among preterm babies presenting with respiratory distress at a tertiary hospital in Tanzania—Randomised trial

BACKGROUND: Respiratory distress syndrome (RDS) is the most common respiratory disease in premature babies and the major cause of morbidity and mortality among preterm babies. Effective treatment of these babies requires exogenous surfactant and/or mechanical ventilation but these are of limited availability in low and middle income countries. A cheaper, simpler and more accessible treatment for preterms with RDS called bubble-continuous positive airway pressure (bCPAP) has been reported to be effective in treating RDS in preterm babies with varying levels of effectiveness ranging from 42% to 85%. We aimed to implement and determine the efficacy of bCPAP and its immediate outcomes as compared to oxygen therapy in preterm babies presenting with respiratory distress at a tertiary hospital in Tanzania. METHOD: A randomized control trial, conducted from December 2016 to May 2017, included all preterm babies admitted at the neonatal care unit presenting with signs of respiratory distress and meeting the inclusion criteria. The primary outcome was survival while the secondary outcomes were treatment duration, duration of hospital stay and treatment complications. RESULTS: A total of 824 babies were admitted in the neonatal care unit during the study period. Of these, 187 babies were preterm and 48 babies were recruited and randomized (25 bCPAP vs 23 oxygen). The overall survival to discharge for all eligible participants (n = 48) was 58.2% compared to those who adhered to treatment protocol (n = 45, 62.2%). Babies in the bCPAP group had higher survival (17/22; 77.3%) as compared to their counterparts in the oxygen therapy group (11/23; 47.8%). Babies treated with bCPAP had 52% lower risk of death (crude HR 0.48, 95% CI = 0.16–1.43) compared to babies receiving oxygen therapy. The median duration of treatment for babies in the oxygen therapy group was 2 (Range 0–16) days compared to 2 (Range 0–5) days in the bCPAP group. The median duration of hospital stay for babies receiving bCPAP was 14 (range 7–43) days. Nasal bleeding was commonly observed among babies in the bCPAP group as compared to those in the oxygen therapy group. CONCLUSION: This study revealed that treatment with bCPAP had a 30% clinical improvement in survival to discharge. Our findings highlight the role of bCPAP in reducing neonatal mortality in resource limited settings but further adequately powered studies in this or similar settings are required.