Safety of sildenafil in extremely premature infants: a phase I 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:
01 2022
01 2022
Historique:
received:
03
08
2021
accepted:
20
10
2021
revised:
16
10
2021
pubmed:
7
11
2021
medline:
20
4
2022
entrez:
6
11
2021
Statut:
ppublish
Résumé
To characterize the safety of sildenafil in premature infants. A phase I, open-label trial of sildenafil in premature infants receiving sildenafil per usual clinical care (cohort 1) or receiving a single IV dose of sildenafil (cohort 2). Safety was evaluated based on adverse events (AEs), transaminase levels, and mean arterial pressure monitoring. Twenty-four infants in cohort 1 (n = 25) received enteral sildenafil. In cohort 2, infants received a single IV sildenafil dose of 0.25 mg/kg (n = 7) or 0.125 mg/kg (n = 2). In cohort 2, there was one serious AE related to study drug involving hypotension associated with a faster infusion rate than specified by the protocol. There were no AEs related to elevated transaminases. Sildenafil was well tolerated by the study population. Drug administration times and flush rates require careful attention to prevent infusion-related hypotension associated with faster infusions of IV sildenafil in premature infants. ClinicalTrials.gov Identifier: NCT01670136.
Identifiants
pubmed: 34741102
doi: 10.1038/s41372-021-01261-w
pii: 10.1038/s41372-021-01261-w
pmc: PMC8569839
doi:
Substances chimiques
Sildenafil Citrate
BW9B0ZE037
Banques de données
ClinicalTrials.gov
['NCT01670136']
Types de publication
Clinical Trial, Phase I
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
31-36Subventions
Organisme : NIAAA NIH HHS
ID : HHSN275201000003C
Pays : United States
Organisme : NICHD NIH HHS
ID : HHSN275201000003I
Pays : United States
Organisme : NHLBI NIH HHS
ID : K24 HL143283
Pays : United States
Informations de copyright
© 2021. The Author(s), under exclusive licence to Springer Nature America, Inc.
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