TY - JOUR
T1 - The bilirubin albumin ratio in the management of hyperbilirubinemia in preterm infants to improve neurodevelopmental outcome: a randomized controlled trial--BARTrial
AU - Hulzebos, Christian V.
AU - Dijk, Peter H.
AU - van Imhoff, Deirdre E.
AU - Bos, Arend F.
AU - Lopriore, Enrico
AU - Offringa, Martin
AU - Ruiter, Selma A. J.
AU - van Braeckel, Koen N. J. A.
AU - Krabbe, Paul F. M.
AU - Quik, Elise H.
AU - van Toledo-Eppinga, Letty
AU - Nuytemans, Debbie H. G. M.
AU - van Wassenaer-Leemhuis, Aleid G.
AU - Benders, Manon J. N.
AU - Korbeeck-van Hof, Karen K. M.
AU - van Lingen, Richard A.
AU - Groot Jebbink, Liesbeth J. M.
AU - Liem, Djien
AU - Mansvelt, Petri
AU - Buijs, Jan
AU - Govaert, Paul
AU - van Vliet, Ineke
AU - Mulder, Twan L. M.
AU - Wolfs, Cecile
AU - Fetter, Willem P. F.
AU - Laarman, Celeste
AU - AUTHOR GROUP
AU - Mulder, A. L. M.
AU - Govaert, P.
AU - van Lingen, R. A.
AU - Lopriore, E.
AU - Buijs, J.
AU - van Imhoff, D. E.
AU - Dijk, P. H.
AU - Hulzebos, C. V.
AU - Liem, K. D.
AU - Benders, M. J. N. L.
AU - Fetter, W. P. F.
PY - 2014
Y1 - 2014
N2 - High bilirubin/albumin (B/A) ratios increase the risk of bilirubin neurotoxicity. The B/A ratio may be a valuable measure, in addition to the total serum bilirubin (TSB), in the management of hyperbilirubinemia. We aimed to assess whether the additional use of B/A ratios in the management of hyperbilirubinemia in preterm infants improved neurodevelopmental outcome. In a prospective, randomized controlled trial, 615 preterm infants of 32 weeks' gestation or less were randomly assigned to treatment based on either B/A ratio and TSB thresholds (consensus-based), whichever threshold was crossed first, or on the TSB thresholds only. The primary outcome was neurodevelopment at 18 to 24 months' corrected age as assessed with the Bayley Scales of Infant Development III by investigators unaware of treatment allocation. Secondary outcomes included complications of preterm birth and death. Composite motor (100 ± 13 vs. 101 ± 12) and cognitive (101 ± 12 vs. 101 ± 11) scores did not differ between the B/A ratio and TSB groups. Demographic characteristics, maximal TSB levels, B/A ratios, and other secondary outcomes were similar. The rates of death and/or severe neurodevelopmental impairment for the B/A ratio versus TSB groups were 15.4% versus 15.5% (P = 1.0) and 2.8% versus 1.4% (P = 0.62) for birth weights ≤ 1000 g and 1.8% versus 5.8% (P = 0.03) and 4.1% versus 2.0% (P = 0.26) for birth weights of >1000 g. The additional use of B/A ratio in the management of hyperbilirubinemia in preterm infants did not improve their neurodevelopmental outcome. Controlled-Trials.com ISRCTN74465643
AB - High bilirubin/albumin (B/A) ratios increase the risk of bilirubin neurotoxicity. The B/A ratio may be a valuable measure, in addition to the total serum bilirubin (TSB), in the management of hyperbilirubinemia. We aimed to assess whether the additional use of B/A ratios in the management of hyperbilirubinemia in preterm infants improved neurodevelopmental outcome. In a prospective, randomized controlled trial, 615 preterm infants of 32 weeks' gestation or less were randomly assigned to treatment based on either B/A ratio and TSB thresholds (consensus-based), whichever threshold was crossed first, or on the TSB thresholds only. The primary outcome was neurodevelopment at 18 to 24 months' corrected age as assessed with the Bayley Scales of Infant Development III by investigators unaware of treatment allocation. Secondary outcomes included complications of preterm birth and death. Composite motor (100 ± 13 vs. 101 ± 12) and cognitive (101 ± 12 vs. 101 ± 11) scores did not differ between the B/A ratio and TSB groups. Demographic characteristics, maximal TSB levels, B/A ratios, and other secondary outcomes were similar. The rates of death and/or severe neurodevelopmental impairment for the B/A ratio versus TSB groups were 15.4% versus 15.5% (P = 1.0) and 2.8% versus 1.4% (P = 0.62) for birth weights ≤ 1000 g and 1.8% versus 5.8% (P = 0.03) and 4.1% versus 2.0% (P = 0.26) for birth weights of >1000 g. The additional use of B/A ratio in the management of hyperbilirubinemia in preterm infants did not improve their neurodevelopmental outcome. Controlled-Trials.com ISRCTN74465643
U2 - https://doi.org/10.1371/journal.pone.0099466
DO - https://doi.org/10.1371/journal.pone.0099466
M3 - Article
C2 - 24927259
SN - 1932-6203
VL - 9
SP - e99466
JO - PLOS ONE
JF - PLOS ONE
IS - 6
M1 - e99466
ER -