Caffeine Citrate for Apnea of Prematurity: A Prospective, Open-Label, Single-Arm Study in Chinese Neonates.

ABSTRACT: Background: Caffeine citrate has been approved in China for the management of apnea of prematurity. This clinical trial was conducted as a condition of regulatory approval. The aim was to confirm the efficacy of caffeine citrate in the treatment of recurrent intermittent hypoxia and bradycardia in preterm newborns with primary apnea. Objectives: The primary outcome was the change from baseline in the number of apnea events after loading dose administration of caffeine citrate. Secondary efficacy outcomes included the change from baseline in apnea events after 2 and 4 weeks of maintenance doses. Methods: This was a multicenter, prospective longitudinal open-label, single-arm study. Neonates who had experienced at least four apnea events during a 24 h period received a l

SUBMITTER: Du L 

PROVIDER: S-EPMC7078308 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature