Document Detail


The effect of antenatal phenobarbital therapy on neonatal intracranial hemorrhage in preterm infants.
MedLine Citation:
PMID:  9250849     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
BACKGROUND: The administration of phenobarbital to pregnant women before delivery has been thought to decrease the frequency of intracranial hemorrhage in preterm infants. To evaluate this potential neuroprotective therapy further, we determined the effect of antenatal administration of phenobarbital on the frequency of neonatal intracranial hemorrhage and early death. METHODS: We studied 610 women who were 24 to 33 weeks pregnant and who were expected to deliver their infants within 24 hours. The women were randomly assigned to receive either phenobarbital (10 mg per kilogram of body weight) or placebo intravenously, followed by maintenance doses until delivery or 34 weeks of gestation. The infants born to these women underwent cranial ultrasonography to detect the presence of intracranial hemorrhage. RESULTS: There were 309 women in the phenobarbital group and 301 in the placebo group. A total of 247 women (80 percent) in the phenobarbital group and 235 (78 percent) in the placebo group delivered within 24 hours after infusion of the study drug or administration of the last maintenance dose. Intracranial hemorrhage or early death occurred in 83 of the 344 infants born to the women in the phenobarbital group (24 percent) and in 74 of the 324 born to the women in the placebo group (23 percent; risk ratio for the infants in the phenobarbital group, 1.1; 95 percent confidence interval, 0.8 to 1.4). Among infants born before 34 weeks' gestation in whom ultrasonographic studies were performed, intracranial hemorrhage was diagnosed in 70 of 311 infants in the phenobarbital group (23 percent) and 64 of 279 in the placebo group (23 percent; risk ratio, 1.0; 95 percent confidence interval, 0.8 to 1.4). CONCLUSIONS: Antenatal administration of phenobarbital does not decrease the risk of intracranial hemorrhage or early death in preterm infants.
Authors:
S Shankaran; L A Papile; L L Wright; R A Ehrenkranz; L Mele; J A Lemons; S B Korones; D K Stevenson; E F Donovan; B J Stoll; A A Fanaroff; W Oh
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Publication Detail:
Type:  Clinical Trial; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, U.S. Gov't, P.H.S.    
Journal Detail:
Title:  The New England journal of medicine     Volume:  337     ISSN:  0028-4793     ISO Abbreviation:  N. Engl. J. Med.     Publication Date:  1997 Aug 
Date Detail:
Created Date:  1997-08-14     Completed Date:  1997-08-14     Revised Date:  2007-11-14    
Medline Journal Info:
Nlm Unique ID:  0255562     Medline TA:  N Engl J Med     Country:  UNITED STATES    
Other Details:
Languages:  eng     Pagination:  466-71     Citation Subset:  AIM; IM    
Affiliation:
Wayne State University, Detroit, MI, USA.
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MeSH Terms
Descriptor/Qualifier:
Adult
Cerebral Hemorrhage / prevention & control*,  ultrasonography
Female
Humans
Infant, Newborn
Infant, Premature
Infant, Premature, Diseases / mortality,  prevention & control*,  ultrasonography
Odds Ratio
Phenobarbital / administration & dosage,  therapeutic use*
Pregnancy
Prenatal Care
Treatment Outcome
Grant Support
ID/Acronym/Agency:
U10 HD21385/HD/NICHD NIH HHS; U10 HD27871/HD/NICHD NIH HHS; U10 HD27881/HD/NICHD NIH HHS
Chemical
Reg. No./Substance:
50-06-6/Phenobarbital

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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