The bilirubin albumin ratio in the management of hyperbilirubinemia in preterm infants to improve neurodevelopmental outcome: A randomized controlled trial - BARTrial

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 th

The Bilirubin Albumin Ratio in the Management of Hyperbilirubinemia in Preterm Infants to Improve Neurodevelopmental Outcome: A Randomized Controlled Trial - BARTrial

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

Outcomes at 18 to 24 months.

<p>Plus-minus values are means ± standard deviations. The denominator used to calculate the percentage of infants with a specific outcome was the number of infants randomly assigned to each treatment group for whom that outcome was known at 18 to 24 months. This number was the total number in each group, unless otherwise specified. The motor and cognitive scores were assessed with the BSID III (scores range from 50 to 150, where 150 indicates most advanced development).</p><p>The relative risk of each outcome was calculated for the BA ratio group as compared to the TSB group. In the B/A ratio group the mean (±SD) age at death was 30±16 days and 10±7 days in the TSB group. Severe NDI was a composite motor score of <70, a composite cognitive score of <70, moderate or severe cerebral palsy, severe unilateral or bilateral hearing loss, or unilateral or bilateral blindness. Neurodevelopmental impairment was a composite motor score of <85, a composite cognitive score of <85, any neurological impairment, any visual impairment, or hearing impairment.</p><p>P value#: Outcomes of t-test for continuous variables or Fischer exact test for categorical variables, two-tailed; RR is relative risk with (95% confidence interval). P value ^$: corresponding P value.</p

Baseline characteristics at randomization.

<p>Plus-minus values are means ± standard deviations. The denominator used to calculate the percentages of infants or mothers with a specific characteristic was the number for whom the characteristic was known. This number was the total number in each group, unless otherwise specified. No significant differences were found between the two groups. # Race or ethnicity was reported by patients' parents or guardians or determined by the physician on reviewing the charts.</p