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document
Vitamin A supplementation for extremely-low-birth-weight infants . National Institute of Child Health and Human Development Neonatal Research Network . BACKGROUND Vitamin A supplementation may reduce the risk of chronic lung disease and sepsis in extremely-low-birth-weight infants . The results of our pilot study suggested that a dose of 5000 IU administered intramuscularly three times per week for four weeks was more effective than the lower doses given in past trials . METHODS We performed a multicenter , blinded , randomized trial to assess the effectiveness and safety of this regimen as compared with sham treatment in 807 infants in need of respiratory support 24 hours after birth . The mean birth weight was 770 g in the vitamin A group and 769 g in the control group , and the respective gestational ages were 26.8 and 26.7 weeks . RESULTS By 36 weeks ' postmenstrual age , 59 of the 405 infants ( 15 percent ) in the vitamin A group and 55 of the 402 infants ( 14 percent ) in the control group had died . The primary outcome - death or chronic lung disease at 36 weeks ' postmenstrual age - occurred in significantly fewer infants in the vitamin A group than in the control group ( 55 percent vs. 62 percent ; relative risk , 0.89 ; 95 percent confidence interval , 0.80 to 0.99 ) . Overall , 1 additional infant survived without chronic lung disease for every 14 to 15 infants who received vitamin A supplements . The proportions of infants in the vitamin A group and the control group who had signs of potential vitamin A toxicity were similar . The proportion of infants with serum retinol values below 20 microg per deciliter ( 0.70 micromol per liter ) was lower in the vitamin A group than in the control group ( 25 percent vs. 54 percent , P < 0.001 ) . CONCLUSIONS Intramuscular administration of 5000 IU of vitamin A three times per week for four weeks reduced biochemical evidence of vitamin A deficiency and slightly decreased the risk of chronic lung disease in extremely-low-birth-weight infants .
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Intervention_Pharmacological
Vitamin A supplementation
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Intervention_Pharmacological
Vitamin A supplementation
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Intervention_Control
sham treatment
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Intervention_Pharmacological
vitamin A
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Intervention_Control
control group
1275
Outcome_Other
effectiveness and safety
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Outcome_Physical
birth weight
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Outcome_Mortality
death
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Outcome_Physical
chronic lung disease
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Outcome_Adverse-effects
potential vitamin A toxicity
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Outcome_Physical
proportion of infants with serum retinol values
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Participant_Condition
extremely-low-birth-weight
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Participant_Age
infants
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Participant_Sample-size
807