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Volume 340:1962-1968 June 24, 1999 Number 25
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Vitamin A Supplementation for Extremely-Low-Birth-Weight Infants
Jon E. Tyson, M.D., M.P.H., Linda L. Wright, M.D., William Oh, M.D., Kathleen A. Kennedy, M.D., Lisa Mele, Sc.M., Richard A. Ehrenkranz, M.D., Barbara J. Stoll, M.D., James A. Lemons, M.D., David K. Stevenson, M.D., Charles R. Bauer, M.D., Sheldon B. Korones, M.D., Avroy A. Fanaroff, M.B., B.Ch., Edward F. Donovan, M.D., M.P.H., Waldemar A. Carlo, M.D., Seetha Shankaran, M.D., Ann R. Stark, M.D., Lu-Ann Papile, M.D., Alan Jobe, M.D., Ph.D., Maria Stacewicz-Sapuntzakis, Ph.D., Joel Verter, Ph.D., for The National Institute of Child Health Human Development Neonatal Research Network

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ABSTRACT

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 µg per deciliter (0.70 µmol 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.


Source Information

From the University of Texas Southwestern Medical Center, Dallas (J.E.T., K.A.K.); the National Institute of Child Health and Human Development, Bethesda, Md. (L.L.W.); Women and Infant's Hospital, Providence, R.I. (W.O.); George Washington University Biostatistics Center, Rockville, Md. (L.M.); Yale University, New Haven, Conn. (R.A.E.); Emory University, Atlanta (B.J.S.); Indiana University, Indianapolis (J.A.L.); Stanford University, Stanford, Calif. (D.K.S.); University of Miami, Miami (C.R.B.); University of Tennessee, Memphis (S.B.K.); and Case Western Reserve University, Cleveland (A.A.F.). Other authors were Edward F. Donovan, M.D., M.P.H., University of Cincinnati, Cincinnati; Waldemar A. Carlo, M.D., University of Alabama, Birmingham; Seetha Shankaran, M.D., Wayne State University, Detroit; Ann R. Stark, M.D., Brigham and Women's Hospital, Boston; Lu-Ann Papile, M.D., University of New Mexico, Albuquerque; Alan Jobe, M.D., Ph.D., Children's Hospital Medical Center, Cincinnati; Maria Stacewicz-Sapuntzakis, Ph.D., University of Illinois at Chicago, Chicago; and Joel Verter, Ph.D., George Washington University Biostatistics Center, Rockville, Md.

Address reprint requests to Dr. Tyson at UT Houston, 6431 Fannin, Suite 3.228, Houston, TX 77030.

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Related Letters:

Vitamin A Supplementation for Extremely-Low-Birth-Weight Infants
Bental Y. A., Rotschild A., Cooper P. A., Boucher B. J., Tyson J.
Extract | Full Text  
N Engl J Med 1999; 341:1697-1698, Nov 25, 1999. Correspondence

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