Oral melatonin as a new tool for neuroprotection in preterm newborns: study protocol for a randomized controlled trial.

ABSTRACT:

Background

Prevention of neurodevelopmental impairment due to preterm birth is a major health challenge. Despite advanced obstetric and neonatal care, to date there are few neuroprotective molecules available. Melatonin has been shown to have anti-oxidant/anti-inflammatory effects and to reduce brain damage, mainly after hypoxic ischemic encephalopathy. The planned study will be the first aiming to evaluate the capacity of melatonin to mitigate brain impairment due to premature birth.

Method

In our planned prospective, multicenter, double-blind, randomized vs placebo study, we will recruit, within 96 h of birth, 60 preterm newborns with a gestational age ≤ 29 weeks + 6 days; these infants will be randomly allocated to oral melatonin, 3 mg/kg/day, or placebo for 15 days. Afte

SUBMITTER: Garofoli F 

PROVIDER: S-EPMC7820522 | biostudies-literature | 2021 Jan

REPOSITORIES: biostudies-literature