학술논문
A randomized control trial of phototherapy and 20% albumin versus phototherapy and saline in Kilifi, Kenya
Document Type
Clinical report
Author
Source
BMC Research Notes. September 23, 2019, Vol. 12 Issue 1
Subject
Language
English
ISSN
1756-0500
Abstract
Author(s): Dorcas N. Magai[sup.1,2] , Michael Mwaniki[sup.1,3] , Amina Abubakar[sup.1,4,5,6] , Shebe Mohammed[sup.1] , Anne L. Gordon[sup.7] , Raphael Kalu[sup.1] , Paul Mwangi[sup.1] , Hans M. Koot[sup.2] and Charles R. [...]
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 ([chl].sup.2 (2) = 0.36, p = 0.546); repeat phototherapy ([chl].sup.2 (2) = 2.37, p = 0.123); and those who died ([chl].sup.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. Keywords: Albumin, Saline, Neonates, Neonatal jaundice, Sub-Saharan Africa
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 ([chl].sup.2 (2) = 0.36, p = 0.546); repeat phototherapy ([chl].sup.2 (2) = 2.37, p = 0.123); and those who died ([chl].sup.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. Keywords: Albumin, Saline, Neonates, Neonatal jaundice, Sub-Saharan Africa