The bilirubin albumin ratio in the management of hyperbilirubinemia in preterm infants to improve neurodevelopmental outcome: a randomized controlled trial--BARTrial.
Autor: | Hulzebos CV; Department of Neonatology, Beatrix Children's Hospital, University Medical Center Groningen, Groningen, The Netherlands., Dijk PH; Department of Neonatology, Beatrix Children's Hospital, University Medical Center Groningen, Groningen, The Netherlands., van Imhoff DE; Department of Neonatology, Beatrix Children's Hospital, University Medical Center Groningen, Groningen, The Netherlands., Bos AF; Department of Neonatology, Beatrix Children's Hospital, University Medical Center Groningen, Groningen, The Netherlands., Lopriore E; Division of Neonatology, Department of Pediatrics, Leiden University Medical Center, Leiden, The Netherlands., Offringa M; Child Health Evaluative Sciences, The Hospital for Sick Children Research Institute, University of Toronto, Toronto, Canada., Ruiter SA; Department of Orthopedagogy, University of Groningen, Groningen, The Netherlands., van Braeckel KN; Department of Neonatology, Beatrix Children's Hospital, University Medical Center Groningen, Groningen, The Netherlands., Krabbe PF; Department of Epidemiology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands., Quik EH; Department of Epidemiology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands., van Toledo-Eppinga L; Department of Neonatology, Emma Children's Hospital Academic Medical Center, Amsterdam, The Netherlands., Nuytemans DH; Department of Neonatology, Emma Children's Hospital Academic Medical Center, Amsterdam, The Netherlands., van Wassenaer-Leemhuis AG; Department of Neonatology, Emma Children's Hospital Academic Medical Center, Amsterdam, The Netherlands., Benders MJ; Department of Neonatology, Wilhelmina Children's Hospital, University Medical Center Utrecht, Utrecht, The Netherlands., Korbeeck-van Hof KK; Department of Neonatology, Wilhelmina Children's Hospital, University Medical Center Utrecht, Utrecht, The Netherlands., van Lingen RA; Princess Amalia Department of Pediatrics, Department of Neonatology, Isala, Zwolle, The Netherlands., Groot Jebbink LJ; Princess Amalia Department of Pediatrics, Department of Neonatology, Isala, Zwolle, The Netherlands., Liem D; Division of Neonatology, Department of Pediatrics, UMC St. Radboud Nijmegen, Nijmegen, The Netherlands., Mansvelt P; Division of Neonatology, Department of Pediatrics, UMC St. Radboud Nijmegen, Nijmegen, The Netherlands., Buijs J; Department of Pediatrics, Máxima Medical Center, Veldhoven, The Netherlands., Govaert P; Erasmus MC, Sophia Children's Hospital, Rotterdam, The Netherlands., van Vliet I; Erasmus MC, Sophia Children's Hospital, Rotterdam, The Netherlands., Mulder TL; Department of Pediatrics, Maastricht University Medical Center, GROW-School for Oncology and Developmental Biology, Maastricht, The Netherlands., Wolfs C; Department of Pediatrics, Maastricht University Medical Center, GROW-School for Oncology and Developmental Biology, Maastricht, The Netherlands., Fetter WP; Department of Pediatrics, VU University Medical Center, Amsterdam, The Netherlands., Laarman C; Department of Pediatrics, VU University Medical Center, Amsterdam, The Netherlands. |
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Jazyk: | angličtina |
Zdroj: | PloS one [PLoS One] 2014 Jun 13; Vol. 9 (6), pp. e99466. Date of Electronic Publication: 2014 Jun 13 (Print Publication: 2014). |
DOI: | 10.1371/journal.pone.0099466 |
Abstrakt: | Background and Objective: 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. Methods: 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. Results: 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. Conclusions: The additional use of B/A ratio in the management of hyperbilirubinemia in preterm infants did not improve their neurodevelopmental outcome. Trial Registration: Controlled-Trials.com ISRCTN74465643. |
Databáze: | MEDLINE |
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