RESUMEN
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.
Asunto(s)
Bilirrubina/análisis , Hiperbilirrubinemia Neonatal/sangre , Hiperbilirrubinemia Neonatal/terapia , Kernicterus/prevención & control , Albúmina Sérica/análisis , Peso al Nacer , Femenino , Humanos , Recién Nacido , Recien Nacido Prematuro , Masculino , Fototerapia , Estudios ProspectivosRESUMEN
OBJECTIVE: To study the reliability and validity of a scoring instrument for the assessment of neonatal resuscitation skills in a training setting. METHODS: Fourteen paediatric residents performed a neonatal resuscitation on a manikin, while being recorded with a video camera. The videotapes were analysed using an existing scoring instrument with an established face and content validity, adjusted for use in a training setting. Intra- and inter-rater reliability were assessed by comparing the ratings of the videotapes of three raters, one of who rated the videotapes twice. Intra-class coefficients (ICC) were calculated for the sum score, percentages of agreement and kappa coefficients for the individual items. To study construct validity, the performance of a second resuscitation of by residents was assessed after they had received feedback on their first performance. RESULTS: The ICC were 0.95 and 0.77 for intra- and inter-rater reliability, respectively. The median percentage of intra-rater agreement was 100%; inter-rater agreement 78.6-84.0%. The median kappa was 0.85 for intra-rater reliability, and 0.42-0.59 for inter-rater reliability. Residents showed a 10% improvement (95% confidence interval -4; 23%) on performance of a second resuscitation, which supports the instrument's construct validity. CONCLUSION: A useful and valid instrument with good intra-rater and reasonable inter-rater reliability is now available for the assessment of neonatal resuscitation skills in a training setting. Its reliability can be improved by using a more advanced manikin and by training of the raters.