Do sick newborn infants benefit from participation in a randomized clinical trial?

Background: Adult participants in randomized controlled trials often have better outcomes than patients who are eligible but not enrolled.

Objective: To examine whether newborn infants who were allocated to placebo in an investigational drug trial had better outcomes than infants who were eligible but not randomized (eligible NR).

Study Design: During a randomized controlled trial of antithrombin therapy in premature infants with respiratory distress syndrome, data were collected prospectively on all 76 infants in the eligible NR group.

A placebo-controlled randomized trial of antithrombin therapy in neonatal respiratory distress syndrome.

Neonatal respiratory distress syndrome (RDS) is associated with decreased plasma activity of antithrombin (AT) and increased formation of thrombin. We tested whether AT reduces thrombin formation, improves gas exchange, and decreases the duration of mechanical ventilation and supplemental oxygen. One hundred twenty-two infants were randomized to pasteurized AT concentrate or to placebo.

Determinants of parental authorization for involvement of newborn infants in clinical trials.

Objective: Parents have the right to decide on behalf of their infants whether to enroll them in controlled clinical trials. We determined the degree to which such parental decisions are influenced by risk and benefit considerations compared with other factors.

Design: Cross-sectional survey.

Does vitamin C cause hemolysis in premature newborn infants? Results of a multicenter double-blind, randomized, controlled trial.

Objective: We tested the hypothesis that vitamin C supplementation of premature neonates is associated with hemolysis.

Study Design: A double-blind, randomized, controlled trial of vitamin C supplementation (50 mg/day) was undertaken in premature neonates (birth weight, 1000 to 1500 gm). Infants were randomly assigned to receive vitamin C (Ce-Vi-Sol) (n = 32) or placebo (n = 24) for 14 days.