Antioxidant Effects of Melatonin in Preterm

Oxidative Stress Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04785183
• Other study ID #: 42/18 - 2018
• Status: Completed
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: September 1, 2020

Study information

• Verified date: March 2021
• Source: Azienda Ospedaliera Universitaria Policlinico "G. Martino"
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: September 1, 2020
• Est. primary completion date: August 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 6 Hours

Eligibility

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.

Related Conditions & MeSH terms

• Melatonin Deficiency
• Newborn Morbidity
• Oxidative Stress
• Pre-Term
• Premature Birth

Intervention

Dietary Supplement:
• Melatonin drops
Melatonin oral administration

Other:
• Placebo
Oral 5% glucose

Locations

Country	Name	City	State
Italy	Eloisa Gitto	Messina

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliera Universitaria Policlinico "G. Martino"

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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