Antioxidant Effects of Melatonin in Preterm

Azienda Ospedaliera Universitaria Policlinico "G. Martino"

Status: Completed

Conditions: Pre-Term; Newborn Morbidity; Melatonin Deficiency; Oxidative Stress

Treatments: Dietary Supplement: Melatonin drops; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04785183

42/18 - 2018

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 1 to 6 hours old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Gestational age <37 weeks
• Normal liver function tests
• Normal kidney function tests

Exclusion criteria

• All babies not born in the clinic
• All babies with severe congenital malformations
• Sepsis
• Inborn errors of metabolism
• Babies suffering from perinatal asphyxia
• Babies born from mothers with mental disorders
• Sample hemolysis
• Insufficient sample
• withdraw informed consent.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups, including a placebo group

Melatonin Group

Experimental group

Treatment:

Dietary Supplement: Melatonin drops

Control Group

Placebo Comparator group

Treatment:

Other: Placebo