Darbepoetin as a neuroprotective agent in mild neonatal encephalopathy: a randomized, placebo-controlled, feasibility trial.
Journal
Journal of perinatology : official journal of the California Perinatal Association
ISSN: 1476-5543
Titre abrégé: J Perinatol
Pays: United States
ID NLM: 8501884
Informations de publication
Date de publication:
06 2021
06 2021
Historique:
received:
08
01
2021
accepted:
28
04
2021
revised:
29
03
2021
pubmed:
15
5
2021
medline:
9
10
2021
entrez:
14
5
2021
Statut:
ppublish
Résumé
To assess the feasibility and safety of one dose of Darbepoetin alpha (Darbe) administered to neonates ≥34 weeks with mild neonatal encephalopathy (NE). 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. 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. 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.
Identifiants
pubmed: 33986477
doi: 10.1038/s41372-021-01081-y
pii: 10.1038/s41372-021-01081-y
pmc: PMC8238874
mid: NIHMS1698690
doi:
Substances chimiques
Neuroprotective Agents
0
Types de publication
Journal Article
Randomized Controlled Trial
Research Support, N.I.H., Extramural
Langues
eng
Sous-ensembles de citation
IM
Pagination
1339-1346Subventions
Organisme : NCATS NIH HHS
ID : UL1 TR001449
Pays : United States
Organisme : NCATS NIH HHS
ID : UL1 TR002538
Pays : United States
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