NCT04785183

Antioxidant Effects of Melatonin in Preterm

Early Supplementation of Melatonin in Preterm Newborns: the Effects on Oxidative Stress

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Azienda Ospedaliera Universitaria Policlinico "G. Martino" · Academic / Other
• Sex: All
• Age: 1 Hour – 6 Hours
• Healthy volunteers: Not accepted

Summary

Preterm infants are at risk of free radical mediated diseases from oxidative stress (OS) injury. Melatonin (MEL) is a powerful antioxidant and scavenger of free radicals. In preterm neonates, melatonin deficiency has been reported. Several studies tested the efficacy of melatonin to counteract oxidative damage in diseases of newborns such as chronic lung disease, perinatal brain injury, necrotizing enterocolitis, retinopathy of prematurity and sepsis, giving promising results. In these studies, the dosages of melatonin varied over a wide range. The present study was designed to test the hypothesis that oral administration of melatonin reduced OS and consequentially, the occurrence of intraventricular haemorrhage (IVH), necrotizing enterocolitis (NEC), retinopathy of prematurity (ROP) and bronchopulmonary dysplasia (BPD) in preterm newborns.

Conditions

• Newborn Morbidity
• Oxidative Stress
• Pre-Term
• Melatonin Deficiency

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Melatonin drops	Melatonin oral administration
OTHER	Placebo	Oral 5% glucose

Timeline

• Start date: 2019-01-01
• Primary completion: 2020-08-01
• Completion: 2020-09-01
• First posted: 2021-03-05
• Last updated: 2021-03-05

Locations

1 site across 1 country: Italy