Antioxidant Effects of Melatonin in Preterm

NCT04785183 | Completed

• 1 other identifier: 42/18 - 2018
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Measurement of AOPP

  All participants will be evaluated at 24 hours of life

• Measurement of NPBI

  All participants will be evaluated at 24 hours of life

• Measurement of isoprostanes

  All participants will be evaluated at 24 hours of life

• Measurement of AOPP

  All participants will be evaluated at 48 hours of life

• Measurement of NPBI

  All participants will be evaluated at 48 hours of life

Other Outcomes (1)

• Evaluation of the free radical diseases of prematurity occurence

  At 3 months of life

Study Arms (2)

Melatonin Group

EXPERIMENTAL

Dietary Supplement: Melatonin drops

Control Group

PLACEBO COMPARATOR

Other: Placebo

Interventions

Melatonin drops DIETARY_SUPPLEMENT

Melatonin oral administration

Melatonin Group

Placebo OTHER

Oral 5% glucose

Control Group

Eligibility Criteria

• Age: 1 Hour - 6 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Eloisa Gitto

Messina, Italy

Location

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2021
• First Posted: March 5, 2021
• Study Start: January 1, 2019
• Primary Completion: August 1, 2020
• Study Completion: September 1, 2020
• Last Updated: March 5, 2021

Record last verified: 2021-03

Locations

IT (1)