A two-phase, double masked, randomized, prospective, multicenter, cooperative study is proposed to test three hypotheses concerning the use of a prophylactic intravenous vitamin E preparation (Hoffmann-LaRoche) versus placebo in infants weighing less than 1500 g at birth for the prevention of three of the most prevalent causes of significant morbidity in this weight group: a) moderate to severe intracranial hemorrhage, b) moderate to severe bronchopulmonary dysplasia, and c) active grade 3 (or worse) retinopathy of prematurity. The doses of vitamin E proposed are designed to maintain a mean serum vitamin E concentration of 3.5 mg/dL. The safety of this dosage regimen will also be assessed with special emphasis on the incidence of bacterial sepsis and necrotizing enterocolitis (problems that have been associated with higher doses of the vitamin). A total of 120 pairs of infants should be sufficient for the first phase in which the incidence of moderate to severe intracranial hemorrhage is examined. The second phase will answer questions concerning bronchopulmonary dysplasia and retinopathy of prematurity. This phase will require a total of 998 pairs of infants to assure statistical significance for either the null hypothesis (alpha less than 0.05) or the alternative hypothesis (beta less than 0.1).
| Fisher, Philip A; Lester, Barry M; DeGarmo, David S et al. (2011) The combined effects of prenatal drug exposure and early adversity on neurobehavioral disinhibition in childhood and adolescence. Dev Psychopathol 23:777-88 |
