Antioxidant Effects of Melatonin in Preterm

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

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.

Study Overview

• Status: Completed
• Conditions: Oxidative Stress; Newborn Morbidity; Pre-Term; Melatonin Deficiency
• Intervention / Treatment: Dietary supplement: Melatonin drops; Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Messina, Italy
    • Eloisa Gitto

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 hour to 6 hours (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Control Group	Other: Placebo; Oral 5% glucose
EXPERIMENTAL: Melatonin Group	Dietary supplement: Melatonin drops; Melatonin oral administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measurement of the melatonin concentration	Analysis of melatonin concentration in treated group (MEL group) and controls (placebo group)	All participants will be evaluated at 24 hours of life
Measurement of the melatonin concentration	Analysis of melatonin concentration in treated group (MEL group) and controls (placebo group)	All participants will be evaluated at 48 hours of life

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measurement of AOPP	Evaluation of advanced oxidative protein products (AOPP) in treated group (MEL group) and controls (placebo group)	All participants will be evaluated at 24 hours of life
Measurement of NPBI	Evaluation of non protein binding iron (NPBI) in treated group (MEL group) and controls (placebo group)	All participants will be evaluated at 24 hours of life
Measurement of isoprostanes	Evaluation of isoprostanes in treated group (MEL group) and controls (placebo group)	All participants will be evaluated at 24 hours of life
Measurement of AOPP	Evaluation of advanced oxidative protein products (AOPP) in treated group (MEL group) and controls (placebo group)	All participants will be evaluated at 48 hours of life
Measurement of NPBI	Evaluation of non protein binding iron (NPBI) in treated group (MEL group) and controls (placebo group)	All participants will be evaluated at 48 hours of life
Measurement of isoprostanes	Evaluation of isoprostanes in treated group (MEL group) and controls (placebo group)	All participants will be evaluated at 48 hours of life

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of the free radical diseases of prematurity occurence	Evaluation of the occurrence of intraventricular haemorrhage (IVH), necrotizing enterocolitis (NEC), retinopathy of prematurity (ROP) and bronchopulmonary dysplasia (BPD)	At 3 months of life

Collaborators and Investigators

• Sponsor: Azienda Ospedaliera Universitaria Policlinico "G. Martino"

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2019
• Primary Completion (ACTUAL): August 1, 2020
• Study Completion (ACTUAL): September 1, 2020

Study Registration Dates

• First Submitted: February 16, 2021
• First Submitted That Met QC Criteria: March 2, 2021
• First Posted (ACTUAL): March 5, 2021

Study Record Updates

• Last Update Posted (ACTUAL): March 5, 2021
• Last Update Submitted That Met QC Criteria: March 2, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Premature Birth; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Protective Agents; Antioxidants; Melatonin
• Other Study ID Numbers: 42/18 - 2018

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No