Illness with fatalities in premature infants

Association with an intravenous vitamin E preparation, E-Ferol

W. J. Martone, W. W. Williams, M. L. Mortensen, R. P. Gaynes, J. W. White, Vichien Lorch, M. D. Murphy, S. N. Sinha, D. J. Frank, N. Kosmetatos

Research output: Contribution to journalArticle

24 Citations (Scopus)

Abstract

Three clusters of an unusual syndrome in premature infants were investigated in three intensive care nurseries in 1984. A retrospective cohort study of 68 infants weighing ≤1,250 g at birth and surviving at least 72 hours revealed that in 13 infants ascites developed and in four at least two of the following abnormal laboratory values were found within a seven-day period: serum direct bilirubin ≥2 mg/dL, blood urea nitrogen ≥40 mg/dL or serum creatinine ≥2 mg/dL, and platelet count ≤60,000/μL. All cases occurred after the introduction and use of intravenous E-Ferol, a vitamin E preparation that was new on the market when the clusters were reported. All 17 case infants but only 23 of 51 (45%) noncase infants received E-Ferol (P < .0001). Case and noncase infants were similar with respect to other complications and to receipt of medications and parenteral nutrition. A dose-response relationship was found; cases occurred in infants receiving E-Ferol dosages of >20 U/kg/d. Case infants who had higher daily doses of E-Ferol had a shorter latency. No new cases were reported after use of E-Ferol was stopped. Results of these investigations led to a nationwide recall of intravenous E-Ferol.

Original languageEnglish (US)
Pages (from-to)591-600
Number of pages10
JournalPediatrics
Volume78
Issue number4
StatePublished - Dec 30 1986

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Tocopherols
Vitamin E
Premature Infants
Nurseries
Blood Urea Nitrogen
Critical Care
Serum
Platelet Count
Bilirubin
Ascites
Creatinine
Cohort Studies
Retrospective Studies
Parturition

All Science Journal Classification (ASJC) codes

  • Pediatrics, Perinatology, and Child Health

Cite this

Martone, W. J., Williams, W. W., Mortensen, M. L., Gaynes, R. P., White, J. W., Lorch, V., ... Kosmetatos, N. (1986). Illness with fatalities in premature infants: Association with an intravenous vitamin E preparation, E-Ferol. Pediatrics, 78(4), 591-600.

Illness with fatalities in premature infants : Association with an intravenous vitamin E preparation, E-Ferol. / Martone, W. J.; Williams, W. W.; Mortensen, M. L.; Gaynes, R. P.; White, J. W.; Lorch, Vichien; Murphy, M. D.; Sinha, S. N.; Frank, D. J.; Kosmetatos, N.

In: Pediatrics, Vol. 78, No. 4, 30.12.1986, p. 591-600.

Research output: Contribution to journalArticle

Martone, WJ, Williams, WW, Mortensen, ML, Gaynes, RP, White, JW, Lorch, V, Murphy, MD, Sinha, SN, Frank, DJ & Kosmetatos, N 1986, 'Illness with fatalities in premature infants: Association with an intravenous vitamin E preparation, E-Ferol', Pediatrics, vol. 78, no. 4, pp. 591-600.
Martone WJ, Williams WW, Mortensen ML, Gaynes RP, White JW, Lorch V et al. Illness with fatalities in premature infants: Association with an intravenous vitamin E preparation, E-Ferol. Pediatrics. 1986 Dec 30;78(4):591-600.
Martone, W. J. ; Williams, W. W. ; Mortensen, M. L. ; Gaynes, R. P. ; White, J. W. ; Lorch, Vichien ; Murphy, M. D. ; Sinha, S. N. ; Frank, D. J. ; Kosmetatos, N. / Illness with fatalities in premature infants : Association with an intravenous vitamin E preparation, E-Ferol. In: Pediatrics. 1986 ; Vol. 78, No. 4. pp. 591-600.
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