A randomized control trial of phototherapy and 20% albumin versus phototherapy and saline in Kilifi, Kenya

Centre for Geographic Medicine Research Coast, Kenya Medical Research Institute, Wellcome Trust Research Programme, PO Box 230-8010, Kilifi, Kenya. dmagai@kemri-wellcome.org. Department of Clinical Neuro- and Developmental Psychology, Vrije Universiteit, Van der Boechorststraat 7, 1081 BT, Amsterdam, The Netherlands. dmagai@kemri-wellcome.org. Centre for Geographic Medicine Research Coast, Kenya Medical Research Institute, Wellcome Trust Research Programme, PO Box 230-8010, Kilifi, Kenya. Afya Research Africa, Nairobi, 00202, Kenya. Department of Public Health, Pwani University, P.O. Box 195-80108, Kilifi, Kenya. Institute for Human Development, Aga Khan University, P.O. Box 30270-00100, Nairobi, Kenya. Department of Psychiatry, University of Oxford, Oxford, OX3 7JX, UK. Faculty of Life Sciences and Medicine, King's College London, Strand, London, WC2R2LS, England, UK. Department of Clinical Neuro- and Developmental Psychology, Vrije Universiteit, Van der Boechorststraat 7, 1081 BT, Amsterdam, The Netherlands.

BMC research notes. 2019;12(1):617
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Abstract
OBJECTIVE The study evaluated the efficacy of phototherapy and 20% albumin infusion to reduce total serum bilirubin (TSB) in neonates with severe hyperbilirubinemia. The primary outcome was a reduction of TSB at the end of treatment. The secondary outcomes were the need for exchange transfusion, inpatient mortality, neurological outcomes at discharge, and development outcomes at 12-months follow-up. RESULTS One hundred and eighteen neonates were randomly assigned to phototherapy and 20% albumin (n = 59) and phototherapy and saline (n = 69). The median age at admission was 5 (interquartile range (IQR) 3-6) days, and the median gestation was 36 (IQR 36-38) weeks. No significant differences were found in the change in TSB (Mann-Whitney U =609, p = 0.98) and rate of change in TSB per hour after treatment (Mann-Whitney U = 540, p = 0.39) between the two groups. There were no significant differences between the two groups in the proportion of participants who required exchange transfusion (chi(2) (2) = 0.36, p = 0.546); repeat phototherapy (chi(2) (2) = 2.37, p = 0.123); and those who died (chi(2) (2) = 0.92, p = 0.337). Trial registration The trial was registered in the International Standardized Randomized Controlled Trial Number (ISRCTN); trial registration number ISRCTN89732754.
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Language : eng
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