Does perinatal phenobarbital exposure affect developmental outcome at age 2?
The objective of this paper is to determine if phenobarbital exposure during pregnancy affects developmental outcome at age 2 years. Between 1991 and 1994, 401 pregnant patients at risk for delivery prior to 34 weeks' gestation were invited to participate; 48 mothers declined entry. Before delivery, pharmacy randomized the pregnant women to receive phenobarbital and vitamin K or identically appearing placebo in a blinded fashion. Developmental follow-up at age 2 years was performed. Children from the treatment group scored significantly lower on the Bayley Mental Developmental Index (mean MDI +/- 1 SD) than children whose mothers were randomized to the placebo group [104 +/- 21 (n = 59) vs. 113 +/- 22 (n = 62), p = 0.023]. Of 36 independent variables, randomization group was one of five that individually contributed to the prediction of the Bayley MDI score (p < 0.05). It was concluded that perinatal phenobarbital therapy may impair developmental outcome.
Thorp
J A
JA
Department of Obstetrics and Gynecology, Saint Luke's Hospital, and University of Missouri School of Medicine, USA.
O'Connor
M
M
Jones
A M
AM
Hoffman
E L
EL
Belden
B
B
D000328:Adult; D000927:Anticonvulsants / Q000008:administration & dosage / Q000627:therapeutic use*; D002492:Central Nervous System Depressants / Q000008:administration & dosage / Q000627:therapeutic use*; D002543:Cerebral Hemorrhage / Q000517:prevention & control; D016009:Chi-Square Distribution; D002657:Child Development / Q000187:drug effects*; D002675:Child, Preschool; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007231:Infant, Newborn; D007234:Infant, Premature; D007235:Infant, Premature, Diseases / Q000517:prevention & control; D007360:Intelligence / Q000187:drug effects; D009048:Motor Skills / Q000187:drug effects; D010634:Phenobarbital / Q000008:administration & dosage / Q000627:therapeutic use*; D010919:Placebos; D011247:Pregnancy; D011297:Prenatal Exposure Delayed Effects; D012044:Regression Analysis; D012307:Risk Factors; D014812:Vitamin K / Q000008:administration & dosage / Q000627:therapeutic use
D000927:Anticonvulsants; D002492:Central Nervous System Depressants; D010919:Placebos; D014812:Vitamin K; D010634:Phenobarbital