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Randomized Controlled Trial
. 2021 Jun;41(6):1339-1346.
doi: 10.1038/s41372-021-01081-y. Epub 2021 May 13.

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

Tara L DuPont  1 , Mariana Baserga  2 , Jean Lowe  3 , Tara Zamora  3 , Sandra Beauman  3 , Robin K Ohls  2
Affiliations
Randomized Controlled Trial

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

Tara L DuPont et al. J Perinatol. 2021 Jun.

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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Conflict of interest statement

Conflicts of Interest: All authors indicate that they have no financial obligations or conflicts of interest to disclose.

Figures

Figure 1
Figure 1
CONSORT Flow Diagram. Numbers of infants who were screened for eligibility randomly assigned to receive Darbepoetin or placebo, and follow to 8–12 months of age.
See this image and copyright information in PMC

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