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OpenTrials
Completed

NCT Number: NCT04785183

Antioxidant Effects of Melatonin in Preterm

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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Key information

Conditions

Newborn Morbidity Female Urogenital Diseases and Pregnancy Complications Melatonin Deficiency Obstetric Labor Complications Obstetric Labor, Premature Oxidative Stress Pre-Term Pregnancy Complications Premature Birth Urogenital Diseases

Age range

1 hour–6 hour

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Eloisa Gitto

Messina, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Melatonin drops

Dietary Supplement

Melatonin oral administration

Placebo

Other

Oral 5% glucose

Primary outcomes

  1. Measurement of the melatonin concentration

    Time frame: All participants will be evaluated at 24 hours of life

    Analysis of melatonin concentration in treated group (MEL group) and controls (placebo group)

  2. Measurement of the melatonin concentration

    Time frame: All participants will be evaluated at 48 hours of life

    Analysis of melatonin concentration in treated group (MEL group) and controls (placebo group)

Secondary outcomes

  1. Measurement of AOPP

    Time frame: 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)

  2. Measurement of NPBI

    Time frame: 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)

  3. Measurement of isoprostanes

    Time frame: All participants will be evaluated at 24 hours of life

    Evaluation of isoprostanes in treated group (MEL group) and controls (placebo group)

  4. Measurement of AOPP

    Time frame: 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)

  5. Measurement of NPBI

    Time frame: 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)

  6. Measurement of isoprostanes

    Time frame: All participants will be evaluated at 48 hours of life

    Evaluation of isoprostanes in treated group (MEL group) and controls (placebo group)

Other outcomes

  1. Evaluation of the free radical diseases of prematurity occurence

    Time frame: At 3 months of life

    Evaluation of the occurrence of intraventricular haemorrhage (IVH), necrotizing enterocolitis (NEC), retinopathy of prematurity (ROP) and bronchopulmonary dysplasia (BPD)

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliera Universitaria Policlinico "G. Martino"

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Mar 5, 2021
Registry last updated
Mar 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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