Elsevier

The Journal of Pediatrics

Volume 131, Issue 5, November 1997, Pages 661-665
The Journal of Pediatrics

The effect of erythropoietin on the transfusion requirements of preterm infants weighing 750 grams or less: A randomized, double-blind, placebo-controlled study☆,☆☆,★

https://doi.org/10.1016/S0022-3476(97)70089-1Get rights and content

Abstract

Background: Clinical trials of erythropoietin (EPO) administration to preterm infants have not focused on infants weighing 750 gm or less, the population most likely to receive multiple transfusions because of large phlebotomy losses. It is unknown whether preterm infants weighing 750 gm or less will respond to EPO by accelerating erythropoiesis, or whether EPO administered to this population will decrease blood transfusions.

Methods: We randomly assigned 28 extremely low birth weight preterm infants (mean ± SEM: 24.7 ± 0.3 weeks’ gestation, 662 ± 14 gm birth weight), in the first 72 hours of life, to receive either EPO (200 U/kg/day) or placebo for 14 days and administered transfusions only according to protocol over a 21-day study period. All infants received 1 mg/kg/day iron dextran in their total parenteral nutrition solution during the 14-day treatment period.

Results: During the 21-day study period, a lower number and volume of transfusions were received by the EPO recipients (4.7 ± 0.7 transfusions per patient and 70 ± 11 ml/kg per patient) than by the placebo recipients (7.5 ± 1.1 transfusions per patient and 112 ± 17 ml/kg per patient; p < 0.05, EPO vs placebo), whereas hematocrits remained similar in the two groups. Reticulocyte counts were similar in both groups on day 1 but were greater in the EPO recipients on day 14 (EPO day 1, 351 ± 53; EPO day 14, 359 ± 40 × 10 3 /μl; placebo day 1, 334 ± 64; placebo day 14, 120 ± 10 × 10 3 /μl; p < 0.01, EPO vs placebo). Serum ferritin concentrations were similar in both groups at the beginning of the study but were greater in the placebo recipients by day 14 (EPO, 262 ± 44 μg/L; placebo, 593 ± 92 μg/L; p < 0.01). No adverse effects of EPO or iron were noted.

Conclusion: The combination of EPO and parenteral iron stimulates erythropoiesis in preterm infants weighing 750 gm or less and results in fewer transfusions during their first 3 weeks of life. (J Pediatr 1997;131:661-5)

Section snippets

Methods

Infants were eligible for study if they weighed 750 gm or less at birth and were 72 hours of age or younger. Infants were ineligible for study if they had documented hemolytic or hemorrhagic disease, if they had neutropenia (defined as an absolute neutrophil count less than 500 cells/μl), if they had evidence of seizures or hypertension, 7, 8 if they had disease requiring major surgery, or if they were deemed unlikely to survive.

Infants were randomly assigned in a double-blind fashion to

Results

Forty-three infants were eligible for study, and 28 infants were enrolled. Parents of five eligible infants refused consent, five infants were deemed too ill to participate (or died), one infant underwent a surgical procedure, and four infants were enrolled in other studies that prevented their enrollment in this study. Characteristics of the 15 EPO recipients and 13 placebo recipients enrolled in the study are shown in Table I . There were no differences between groups in birth weight,

Discussion

VLBW infants are less capable than term infants of compensating for blood loss. 11, 12, 13 The large number of transfusions (and associated infectious risks) given to VLBW infants in the first few weeks of life remains a significant problem. 14 One alternative to transfusions is the use of EPO, which has been shown to be efficacious and cost-effective in “older” preterm infants with symptomatic anemia. 15, 16, 17, 18, 19, 20, 21 EPO has not been studied thoroughly in ELBW infants, a population

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    ☆

    Supported by grants HD-00988, HL-44951, HD-01006, RR-00064, RR-00082, and RR-00997 from the National Institutes of Health and by an award from The Children's Miracle Network Telethon.

    ☆☆

    Reprint requests: Robin K. Ohls, MD, University of New Mexico School of Medicine, Department of Pediatrics, Albuquerque, New Mexico 87131-5311.

    ★

    0022-3476/97/$5.00 + 0 9/21/83015

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