Document Detail


Vitamin A supplementation for extremely-low-birth-weight infants. National Institute of Child Health and Human Development Neonatal Research Network.
MedLine Citation:
PMID:  10379020     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
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.
Authors:
J E Tyson; L L Wright; W Oh; K A Kennedy; L Mele; R A Ehrenkranz; B J Stoll; J A Lemons; D K Stevenson; C R Bauer; S B Korones; A A Fanaroff
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:  340     ISSN:  0028-4793     ISO Abbreviation:  N. Engl. J. Med.     Publication Date:  1999 Jun 
Date Detail:
Created Date:  1999-06-24     Completed Date:  1999-06-24     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:  1962-8     Citation Subset:  AIM; IM    
Affiliation:
University of Texas Southwestern Medical Center, Dallas, USA.
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MeSH Terms
Descriptor/Qualifier:
Chronic Disease
Cross Infection / prevention & control
Humans
Infant Mortality
Infant, Newborn
Infant, Very Low Birth Weight* / blood
Injections, Intramuscular
Lung Diseases / prevention & control*
Sepsis / prevention & control
Single-Blind Method
Vitamin A / blood,  therapeutic use*
Grant Support
ID/Acronym/Agency:
U10 HD19897/HD/NICHD NIH HHS; U10 HD21373/HD/NICHD NIH HHS; U10 HD27904/HD/NICHD NIH HHS
Chemical
Reg. No./Substance:
11103-57-4/Vitamin A
Comments/Corrections
Comment In:
N Engl J Med. 1999 Nov 25;341(22):1697; author reply 1698   [PMID:  10610437 ]
N Engl J Med. 1999 Nov 25;341(22):1697; author reply 1698   [PMID:  10610438 ]

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


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