OBJECTIVE: To determine whether postnatal vitamin A therapy increased ductal closure rate in premature infants. STUDY DESIGN: This was a prospective, double-blind, placebo-controlled trial. Subjects (n=40) were recruited on day of life 1. Inclusion criteria were premature neonates weighing 500 to 1500 g with an indwelling umbilical line. Vitamin A was administered intramuscularly on days 1, 3, and 7. Blood vitamin A and retinol binding protein levels were obtained on days 1 and 3. Echocardiography was performed on days 1, 3, 7, and 14. Failure of ductal closure was defined as the presence of a moderate to large patent ductus arteriosus on day 14, indomethacin therapy, or surgical ligation. RESULTS: Comparison between the treatment and placebo groups revealed no differences in gestational age, weight, or oxygenation index. Vitamin A and retinol binding protein levels did not differ between the groups at entry but increased significantly after vitamin A treatment. Failure of ductal closure occurred in 22 of 40 babies without any difference between the groups (12/22 vs 10/18, P=NS). Four infants required surgical ligation, all in the treatment group (P=.04). Clinical outcome did not vary between groups. CONCLUSION:Postnatal vitamin A therapy did not improve ductal closure rates in premature infants.
RCT Entities:
OBJECTIVE: To determine whether postnatal vitamin A therapy increased ductal closure rate in premature infants. STUDY DESIGN: This was a prospective, double-blind, placebo-controlled trial. Subjects (n=40) were recruited on day of life 1. Inclusion criteria were premature neonates weighing 500 to 1500 g with an indwelling umbilical line. Vitamin A was administered intramuscularly on days 1, 3, and 7. Blood vitamin A and retinol binding protein levels were obtained on days 1 and 3. Echocardiography was performed on days 1, 3, 7, and 14. Failure of ductal closure was defined as the presence of a moderate to large patent ductus arteriosus on day 14, indomethacin therapy, or surgical ligation. RESULTS: Comparison between the treatment and placebo groups revealed no differences in gestational age, weight, or oxygenation index. Vitamin A and retinol binding protein levels did not differ between the groups at entry but increased significantly after vitamin A treatment. Failure of ductal closure occurred in 22 of 40 babies without any difference between the groups (12/22 vs 10/18, P=NS). Four infants required surgical ligation, all in the treatment group (P=.04). Clinical outcome did not vary between groups. CONCLUSION: Postnatal vitamin A therapy did not improve ductal closure rates in premature infants.