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Darbepoetin as a neuroprotective agent in mild neonatal encephalopathy: a randomized, placebo-controlled, feasibility trial

Journal of Perinatology volume 41, pages 1339–1346 (2021)Cite this article

Subjects

Abstract

Objective

To assess the feasibility and safety of one dose of Darbepoetin alpha (Darbe) administered to neonates ≥34 weeks with mild neonatal encephalopathy (NE).

Methods

Randomized, masked, placebo-controlled study including neonates ≥34 weeks gestation with mild NE. Neonates were randomized to receive one dose of Darbe (10 μg/kg IV) or placebo. Clinical and laboratory maternal and newborn data were collected. The Bayley Scales of Infant and Toddler Development, third edition (Bayley-III) and a standardized neurological examination at 8–12 months of corrected age were assessed.

Results

There were no differences in baseline characteristics of the 21 infants randomized (9 Darbe, 12 placebo). Adverse events were not reported at any time. Bayley-III scores were average in both Darbe and placebo groups.

Conclusion

This study demonstrates that a randomized, masked, placebo-controlled trial is safe and feasible. A large, randomized trial is warranted to assess the effect of Darbe in this population.

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Fig. 1: CONSORT flow diagram.

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Acknowledgements

We wish to thank the research coordinators and bedside nurses involved in the study, and we are indebted to the parents for their willingness to allow their children to participate in this study. We also wish to thank Tim Bahr, MD, with the University of Utah Department of Pediatrics and Yue Zhang and Zhining Ou with the University of Utah Study Design and Biostatistics Center for their statistical support. We would also like to thank our data safety monitoring committee, John Phillips, MD, Kristi Watterberg, MD, Pablo Sanchez, MD, and Lauren Jantzie, PhD.

Funding

This project was supported by the National Center for Research Resources and the National Center for Advancing Translational Science of the National Institute of Health through Grant Number UL1TR001449.

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Authors and Affiliations

  1. University of Utah, Salt Lake City, UT, USA

    Tara L. DuPont, Mariana Baserga & Robin K. Ohls

  2. University of New Mexico, Albuquerque, NM, USA

    Jean Lowe, Tara Zamora & Sandra Beauman

Authors
  1. Tara L. DuPont
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  2. Mariana Baserga
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Correspondence to Tara L. DuPont.

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DuPont, T.L., Baserga, M., Lowe, J. et al. Darbepoetin as a neuroprotective agent in mild neonatal encephalopathy: a randomized, placebo-controlled, feasibility trial. J Perinatol 41, 1339–1346 (2021). https://doi.org/10.1038/s41372-021-01081-y

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