Antioxidant Effects of Melatonin in Preterm

Not Applicable

Completed

• Conditions: Newborn Morbidity; Oxidative Stress; Pre-Term; Melatonin Deficiency
• Interventions: Other: Placebo; Dietary Supplement: Melatonin drops

• Registration Number: NCT04785183
• Lead Sponsor: Azienda Ospedaliera Universitaria Policlinico "G. Martino"

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-01
• Primary Completion: 2020-08-01
• Study Completion: 2020-09-01
• Study First Submitted: 2021-02-16
• Status Verified: 2021-03
• Study First Submitted QC: 2021-03-02
• Last Update Submitted: 2021-03-02
• Study First Posted: 2021-03-05
• Last Update Posted: 2021-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	Placebo	-
Melatonin Group	Melatonin drops	-

Primary Outcome Measures

Name	Time	Method
Measurement of the melatonin concentration	All participants will be evaluated at 48 hours of life	Analysis of melatonin concentration in treated group (MEL group) and controls (placebo group)

Secondary Outcome Measures

Name	Time	Method
Measurement of AOPP	All participants will be evaluated at 48 hours of life	Evaluation of advanced oxidative protein products (AOPP) in treated group (MEL group) and controls (placebo group)
Measurement of NPBI	All participants will be evaluated at 48 hours of life	Evaluation of non protein binding iron (NPBI) in treated group (MEL group) and controls (placebo group)
Measurement of isoprostanes	All participants will be evaluated at 48 hours of life	Evaluation of isoprostanes in treated group (MEL group) and controls (placebo group)

Trial Locations

Locations (1)

Eloisa Gitto; 🇮🇹 Messina, Italy