RESUMEN
Glucose-6-phosphate dehydrogenase (G6PD) deficiency, a common X-linked enzymopathy can lead to severe hyperbilirubinemia, acute bilirubin encephalopathy and kernicterus in the United States. Neonatal testing for G6PD deficiency is not yet routine and the American Academy of Pediatrics recommends testing only in jaundiced newborns who are receiving phototherapy whose family history, ethnicity, or geographic origin suggest risk for the condition, or for infants whose response to phototherapy is poor. Screening tests for G6PD deficiency are available, are suitable for use in newborns and have been used in birth hospitals. However, US birth hospitals experience is limited and no national consensus has emerged regarding the need for newborn G6PD testing, its effectiveness or the best approach. Our review of current state of G6PD deficiency screening highlights research gaps and informs specific operational challenges to implement universal newborn G6PD testing concurrent to bilirubin screening in the United States.
Asunto(s)
Deficiencia de Glucosafosfato Deshidrogenasa/diagnóstico , Tamizaje Neonatal/estadística & datos numéricos , Negro o Afroamericano/estadística & datos numéricos , Eritroblastosis Fetal/diagnóstico , Deficiencia de Glucosafosfato Deshidrogenasa/epidemiología , Deficiencia de Glucosafosfato Deshidrogenasa/etnología , Humanos , Hiperbilirrubinemia Neonatal/diagnóstico , Hiperbilirrubinemia Neonatal/epidemiología , Hiperbilirrubinemia Neonatal/prevención & control , Recién Nacido , Kernicterus/prevención & control , Tamizaje Neonatal/métodos , Educación del Paciente como Asunto , Reproducibilidad de los Resultados , Medición de Riesgo , Estados Unidos/epidemiologíaRESUMEN
OBJECTIVE: The objective of the study was to examine the variation among institutional review boards (IRBs) in evaluation of the study design of a multicenter trial. STUDY DESIGN: We assessed the first written response of local IRBs to each site investigator for a multicenter trial of vitamin A supplementation in extremely low birth weight (ELBW) infants performed by the National Institute of Child Health and Human Development Neonatal Research Network. Each author of this paper independently reviewed and categorized IRB concerns as major, minor or none, according to the predefined criteria. RESULT: Initially, 9 of 18 IRBs withheld approval because of at least one major concern. These concerns reflected difficulties in evaluating specific scientific issues for the design of the trial, including its justification, enrollment criteria, control and experimental therapies, co-interventions, toxicity assessment, outcome monitoring and informed consent. CONCLUSION: The difficulty in assessing appropriate trial design for the specific hypothesis under investigation resulted in considerable variability in the evaluation by local IRBs.
Asunto(s)
Comités de Ética en Investigación/normas , Estudios Multicéntricos como Asunto/normas , Ensayos Clínicos Controlados Aleatorios como Asunto/normas , Proyectos de Investigación/normas , Suplementos Dietéticos , Humanos , Recien Nacido con Peso al Nacer Extremadamente Bajo , Recién Nacido , Recien Nacido Prematuro , Vitamina A/uso terapéuticoRESUMEN
OBJECTIVES: Infants of