Antioxidant Effects of Melatonin in Preterm

Sponsor

Azienda Ospedaliera Universitaria Policlinico "G. Martino" (Other)

Overall Status

Completed

CT.gov ID

NCT04785183

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

2.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Newborn Morbidity Oxidative Stress Pre-Term Melatonin Deficiency	Dietary Supplement: Melatonin drops Other: Placebo	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 1, 2019

Actual Primary Completion Date :

Aug 1, 2020

Actual Study Completion Date :

Sep 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Melatonin Group	Dietary Supplement: Melatonin drops Melatonin oral administration
Placebo Comparator: Control Group	Other: Placebo Oral 5% glucose

Arm

Intervention/Treatment

Experimental: Melatonin Group

Dietary Supplement: Melatonin drops

Melatonin oral administration

Placebo Comparator: Control Group

Other: Placebo

Oral 5% glucose

Outcome Measures

Primary Outcome Measures

Measurement of the melatonin concentration [All participants will be evaluated at 24 hours of life]
Analysis of melatonin concentration in treated group (MEL group) and controls (placebo group)
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

Measurement of AOPP [All participants will be evaluated at 24 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 24 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 24 hours of life]
Evaluation of isoprostanes in treated group (MEL group) and controls (placebo group)
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)

Other Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Hour to 6 Hours

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Eloisa Gitto	Messina		Italy

Sponsors and Collaborators

Azienda Ospedaliera Universitaria Policlinico "G. Martino"

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Azienda Ospedaliera Universitaria Policlinico "G. Martino"

ClinicalTrials.gov Identifier:

NCT04785183

Other Study ID Numbers:

42/18 - 2018

First Posted:

Mar 5, 2021

Last Update Posted:

Mar 5, 2021

Last Verified:

Mar 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Premature Birth

Melatonin

Study Results

No Results Posted as of Mar 5, 2021