A randomized, double-blind study to determine the effect of intramuscular vitamin E on mortality and intracranial hemorrhage (ICH) was performed. One hundred forty-nine neonates with birth weights ≤l000 g and ≤24 hours of age were grouped by weight (501 to 750 g and 751 to 1000 g) and randomized to treatment or control. The treatment group received intramuscular injections of vitamin E (dl-α-tocopherol) on days 1, 2, 4, and 6 of life. The control group received intramuscular injections of placebo on the same schedule. All neonates initially received oral vitamin E (100 mg/kg/day dl-α-tocopheryl acetate), which was subsequently adjusted to keep serum levels at 0.5 to 3.5 mg/dL. Ultrasonographic examinations of the head were performed as possible on days 1, 5 to 7, and 12 to 14. Hemorrhage was defined as mild if less than or equal to grade II ICH, or severe if grade III or IV. No significant differences in neonatal or total hospital mortality between groups were found. However, all ICH, as well as severe ICH, were significantly less in the vitamin E-treated 501 to 750-g subgroup (all ICH: 60% vs 29%; severe ICH: 32% vs 4%). When survivors were analyzed separately, a significant decrease in severe ICH was seen in the vitamin E-treated neonates (25% vs 5%). Necrotizing enterocolitis and sepsis did not occur more frequently in the neonates treated with intramuscular injections of vitamin E. Other than two cases of mild induration at injection sites, no deleterious side effects of treatment were identified. Vitamin E may have a role in the prevention of severe ICH in premature neonates weighing between 501 and 750 g.
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April 1990
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April 01 1990
Effect of Intramuscular Vitamin E on Mortality and Intracranial Hemorrhage in Neonates of 1000 Grams or Less
Wendy H. Fish;
Wendy H. Fish
From the Departments of Pediatrics, Radiology, and Pharmacy, Indiana University School of Medicine, Indianapolis, Indiana
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Mervyn Cohen;
Mervyn Cohen
From the Departments of Pediatrics, Radiology, and Pharmacy, Indiana University School of Medicine, Indianapolis, Indiana
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Deborah Franzek;
Deborah Franzek
From the Departments of Pediatrics, Radiology, and Pharmacy, Indiana University School of Medicine, Indianapolis, Indiana
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Janice M. Williams;
Janice M. Williams
From the Departments of Pediatrics, Radiology, and Pharmacy, Indiana University School of Medicine, Indianapolis, Indiana
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James A. Lemons
James A. Lemons
From the Departments of Pediatrics, Radiology, and Pharmacy, Indiana University School of Medicine, Indianapolis, Indiana
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Pediatrics (1990) 85 (4): 578–584.
Article history
Received:
June 17 1989
Accepted:
December 08 1989
Citation
Wendy H. Fish, Mervyn Cohen, Deborah Franzek, Janice M. Williams, James A. Lemons; Effect of Intramuscular Vitamin E on Mortality and Intracranial Hemorrhage in Neonates of 1000 Grams or Less. Pediatrics April 1990; 85 (4): 578–584. 10.1542/peds.85.4.578
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