A phase I trial of caffeine to evaluate safety in infants with hypoxic-ischemic encephalopathy.
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:
16 Aug 2023
16 Aug 2023
Historique:
received:
19
05
2023
accepted:
09
08
2023
revised:
28
07
2023
medline:
17
8
2023
pubmed:
17
8
2023
entrez:
16
8
2023
Statut:
aheadofprint
Résumé
Caffeine provides neuroprotection following hypoxic-ischemic injury in animals. We characterized the safety of escalating doses of caffeine in infants with hypoxic-ischemic encephalopathy (HIE) receiving therapeutic hypothermia. Phase I trial of infants undergoing therapeutic hypothermia for HIE receiving IV caffeine 20 mg/kg followed by up to two daily doses of 5 mg/kg (n = 9) or 10 mg/kg (n = 8). Safety was evaluated based on adverse events and frequency of pre-specified outcomes compared to data from the Whole-Body Hypothermia for HIE trial (Shankaran, 2005). Twelve of 17 (71%) infants had ≥1 adverse event during the study period. The frequency of clinical outcomes related to HIE were not statistically different from outcomes in infants receiving hypothermia in the Whole-Body Hypothermia for HIE trial. Caffeine administration was well tolerated. A larger study is required to determine the optimal dose and evaluate drug safety and efficacy. ClinicalTrials.gov Identifier: NCT03913221.
Identifiants
pubmed: 37587184
doi: 10.1038/s41372-023-01752-y
pii: 10.1038/s41372-023-01752-y
doi:
Banques de données
ClinicalTrials.gov
['NCT03913221']
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Subventions
Organisme : NHLBI NIH HHS
ID : K24 HL143283
Pays : United States
Informations de copyright
© 2023. The Author(s), under exclusive licence to Springer Nature America, Inc.
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