Vitamin A supplementation for extremely-low-birth-weight infants

Jon E. Tyson, Linda L. Wright, William Oh, Kathleen A. Kennedy, Lisa Mele, Richard A. Ehrenkranz, Barbara J. Stoll, James A. Lemons, David K. Stevenson, Charles R Bauer, Sheldon B. Korones, Avroy A. Fanaroff, Edward F. Donovan, Waldemer A. Carlo, Seetha Shankaran, Anne R. Stark, Lu Ann Papile, Alan Jobe, Maria Stacewiscz-Sapuntzakis, Joel Verter

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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.

Original languageEnglish
Pages (from-to)1962-1968
Number of pages7
JournalNew England Journal of Medicine
Volume340
Issue number25
DOIs
StatePublished - Jun 24 1999

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Extremely Low Birth Weight Infant
Vitamin A
Lung Diseases
Chronic Disease
Control Groups
Vitamin A Deficiency
Birth Weight
Gestational Age
Sepsis
Placebos

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Tyson, J. E., Wright, L. L., Oh, W., Kennedy, K. A., Mele, L., Ehrenkranz, R. A., ... Verter, J. (1999). Vitamin A supplementation for extremely-low-birth-weight infants. New England Journal of Medicine, 340(25), 1962-1968. https://doi.org/10.1056/NEJM199906243402505

Vitamin A supplementation for extremely-low-birth-weight infants. / Tyson, Jon E.; Wright, Linda L.; Oh, William; Kennedy, Kathleen A.; Mele, Lisa; Ehrenkranz, Richard A.; Stoll, Barbara J.; Lemons, James A.; Stevenson, David K.; Bauer, Charles R; Korones, Sheldon B.; Fanaroff, Avroy A.; Donovan, Edward F.; Carlo, Waldemer A.; Shankaran, Seetha; Stark, Anne R.; Papile, Lu Ann; Jobe, Alan; Stacewiscz-Sapuntzakis, Maria; Verter, Joel.

In: New England Journal of Medicine, Vol. 340, No. 25, 24.06.1999, p. 1962-1968.

Research output: Contribution to journalArticle

Tyson, JE, Wright, LL, Oh, W, Kennedy, KA, Mele, L, Ehrenkranz, RA, Stoll, BJ, Lemons, JA, Stevenson, DK, Bauer, CR, Korones, SB, Fanaroff, AA, Donovan, EF, Carlo, WA, Shankaran, S, Stark, AR, Papile, LA, Jobe, A, Stacewiscz-Sapuntzakis, M & Verter, J 1999, 'Vitamin A supplementation for extremely-low-birth-weight infants', New England Journal of Medicine, vol. 340, no. 25, pp. 1962-1968. https://doi.org/10.1056/NEJM199906243402505
Tyson JE, Wright LL, Oh W, Kennedy KA, Mele L, Ehrenkranz RA et al. Vitamin A supplementation for extremely-low-birth-weight infants. New England Journal of Medicine. 1999 Jun 24;340(25):1962-1968. https://doi.org/10.1056/NEJM199906243402505
Tyson, Jon E. ; Wright, Linda L. ; Oh, William ; Kennedy, Kathleen A. ; Mele, Lisa ; Ehrenkranz, Richard A. ; Stoll, Barbara J. ; Lemons, James A. ; Stevenson, David K. ; Bauer, Charles R ; Korones, Sheldon B. ; Fanaroff, Avroy A. ; Donovan, Edward F. ; Carlo, Waldemer A. ; Shankaran, Seetha ; Stark, Anne R. ; Papile, Lu Ann ; Jobe, Alan ; Stacewiscz-Sapuntzakis, Maria ; Verter, Joel. / Vitamin A supplementation for extremely-low-birth-weight infants. In: New England Journal of Medicine. 1999 ; Vol. 340, No. 25. pp. 1962-1968.
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AU - Tyson, Jon E.

AU - Wright, Linda L.

AU - Oh, William

AU - Kennedy, Kathleen A.

AU - Mele, Lisa

AU - Ehrenkranz, Richard A.

AU - Stoll, Barbara J.

AU - Lemons, James A.

AU - Stevenson, David K.

AU - Bauer, Charles R

AU - Korones, Sheldon B.

AU - Fanaroff, Avroy A.

AU - Donovan, Edward F.

AU - Carlo, Waldemer A.

AU - Shankaran, Seetha

AU - Stark, Anne R.

AU - Papile, Lu Ann

AU - Jobe, Alan

AU - Stacewiscz-Sapuntzakis, Maria

AU - Verter, Joel

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N2 - 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.

AB - 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.

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