Antioxidant Effects of Melatonin in Preterm

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-01

Study Completion Date

2020-09-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Newborn Morbidity Oxidative Stress Pre-Term Melatonin Deficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Caregivers Investigators

Study Groups

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Melatonin Group

Group Type EXPERIMENTAL

Melatonin drops

Intervention Type DIETARY_SUPPLEMENT

Melatonin oral administration

Control Group

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Oral 5% glucose

Interventions

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Melatonin drops

Melatonin oral administration

Intervention Type DIETARY_SUPPLEMENT

Placebo

Oral 5% glucose

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

1 Hour

Maximum Eligible Age

6 Hours

Eligible Sex

ALL

Accepts Healthy Volunteers

No