Published online November 1, 2004
PEDIATRICS Vol. 114 No. 5 November 2004, pp. 1287-1291 (doi:10.1542/peds.2003-1129-L)

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Neurodevelopmental Outcome and Growth at 18 to 22 Months' Corrected Age in Extremely Low Birth Weight Infants Treated With Early Erythropoietin and Iron

Robin K. Ohls, MD^*, Richard A. Ehrenkranz, MD, Abhik Das, PhD, Anna M. Dusick, MD^||, Kimberly Yolton, MD^¶, Elaine Romano, MSN, CPNP, Virginia Delaney-Black, MD^#, Lu-Ann Papile, MD^*, Neal P. Simon, MD^**, Jean J. Steichen, MD, Kimberly G. Lee, MD^,|||| for the National Institute of Child Health and Human Development Neonatal Research Network

^* Department of Pediatrics, University of New Mexico, Albuquerque, New Mexico
Department of Pediatrics, Yale University, New Haven, Connecticut
Research Triangle Institute, Research Triangle Park, North Carolina
^|| Department of Pediatrics, Indiana University, Indianapolis, Indiana
^¶ Newborn Center, University of Tennessee, Memphis, Tennessee
^# Division of Neonatal and Perinatal Medicine, Wayne State University, Detroit, Michigan
^** Department of Pediatrics, Emory University, Atlanta, Georgia
Department of Pediatrics, University of Cincinnati, Cincinnati, Ohio
Joint Program in Neonatology, Harvard University, Boston, Massachusetts
^|||| National Institute of Child Health and Human Development, Bethesda, Maryland

Background. Clinical trials evaluating the use of erythropoietin (Epo) have demonstrated a limited reduction in transfusions; however, long-term developmental follow-up data are scarce.

Objective. We compared anthropometric measurements, postdischarge events, need for transfusions, and developmental outcomes at 18 to 22 months' corrected age in extremely low birth weight (ELBW) infants treated with early Epo and supplemental iron therapy with that of placebo/control infants treated with supplemental iron alone.

Methods. The National Institute of Child Health and Human Development Neonatal Research Network completed a randomized, controlled trial of early Epo and iron therapy in preterm infants 1250 g. A total of 172 ELBW (1000-g birth weight) infants were enrolled (87 Epo and 85 placebo/control). Of the 72 Epo-treated and 70 placebo/control ELBW infants surviving to discharge, follow-up data (growth, development, rehospitalization, transfusions) at 18 to 22 months' corrected age were collected on 51 of 72 Epo-treated infants (71%) and 51 of 70 placebo/controls (73%) by certified examiners masked to the treatment group. Statistical significance was determined using ² analysis.

Results. There were no significant differences between treatment groups in weight or length or in the percentage of infants weighing <10th percentile either at the time of discharge or at follow-up, and no difference was found in the mean head circumference between groups. A similar percentage of infants in each group was rehospitalized (38% Epo and 35% placebo/control) for similar reasons. There were no differences between groups with respect to the percentage of infants with Bayley-II Mental Developmental Index <70 (34% Epo and 36% placebo/control), blindness (0% Epo and 2% placebo/control), deafness or hearing loss requiring amplification (2% Epo and 2% placebo/control), moderate to severe cerebral palsy (16% Epo and 18% placebo/control) or the percentage of infants with any of the above-described neurodevelopmental impairments (42% Epo and 44% placebo/control).

Conclusions. Treatment of ELBW infants with early Epo and iron does not significantly influence anthropometric measurements, need for rehospitalization, transfusions after discharge, or developmental outcome at 18 to 22 months' corrected age.

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Key Words: erythropoietin • parenteral iron • neurodevelopment • preterm infant

Abbreviations: Epo, erythropoietin • ELBW, extremely low birth weight • NICHD, National Institute of Child Health and Human Development • CSF, cerebral spinal fluid • BPD, bronchopulmonary dysplasia • IVH, intraventricular hemorrhage • NEC, necrotizing enterocolitis • NDI, neurodevelopmental impairment • MDI, Mental Developmental Index • PDI, Psychomotor Developmental Index

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Accepted Apr 28, 2004.

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