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Darbepoetin as a Neuroprotective Agent in Mild Neonatal Encephalopathy: A Randomized, Placebo Controlled, Feasibility Trial
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 re...
Autores principales: | , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
2021
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8238874/ https://www.ncbi.nlm.nih.gov/pubmed/33986477 http://dx.doi.org/10.1038/s41372-021-01081-y |
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author | DuPont, Tara L Baserga, Mariana Lowe, Jean Zamora, Tara Beauman, Sandra Ohls, Robin K |
author_facet | DuPont, Tara L Baserga, Mariana Lowe, Jean Zamora, Tara Beauman, Sandra Ohls, Robin K |
author_sort | DuPont, Tara L |
collection | PubMed |
description | 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 corrected age was 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. |
format | Online Article Text |
id | pubmed-8238874 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
record_format | MEDLINE/PubMed |
spelling | pubmed-82388742021-11-13 Darbepoetin as a Neuroprotective Agent in Mild Neonatal Encephalopathy: A Randomized, Placebo Controlled, Feasibility Trial DuPont, Tara L Baserga, Mariana Lowe, Jean Zamora, Tara Beauman, Sandra Ohls, Robin K J Perinatol Article 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 corrected age was 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. 2021-05-13 2021-06 /pmc/articles/PMC8238874/ /pubmed/33986477 http://dx.doi.org/10.1038/s41372-021-01081-y Text en http://www.nature.com/authors/editorial_policies/license.html#termsUsers may view, print, copy, and download text and data-mine the content in such documents, for the purposes of academic research, subject always to the full Conditions of use: http://www.nature.com/authors/editorial_policies/license.html#terms |
spellingShingle | Article DuPont, Tara L Baserga, Mariana Lowe, Jean Zamora, Tara Beauman, Sandra Ohls, Robin K Darbepoetin as a Neuroprotective Agent in Mild Neonatal Encephalopathy: A Randomized, Placebo Controlled, Feasibility Trial |
title | Darbepoetin as a Neuroprotective Agent in Mild Neonatal Encephalopathy: A Randomized, Placebo Controlled, Feasibility Trial |
title_full | Darbepoetin as a Neuroprotective Agent in Mild Neonatal Encephalopathy: A Randomized, Placebo Controlled, Feasibility Trial |
title_fullStr | Darbepoetin as a Neuroprotective Agent in Mild Neonatal Encephalopathy: A Randomized, Placebo Controlled, Feasibility Trial |
title_full_unstemmed | Darbepoetin as a Neuroprotective Agent in Mild Neonatal Encephalopathy: A Randomized, Placebo Controlled, Feasibility Trial |
title_short | Darbepoetin as a Neuroprotective Agent in Mild Neonatal Encephalopathy: A Randomized, Placebo Controlled, Feasibility Trial |
title_sort | darbepoetin as a neuroprotective agent in mild neonatal encephalopathy: a randomized, placebo controlled, feasibility trial |
topic | Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8238874/ https://www.ncbi.nlm.nih.gov/pubmed/33986477 http://dx.doi.org/10.1038/s41372-021-01081-y |
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