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Antioxidant Effects of Melatonin in Preterm

Primary Purpose

Newborn Morbidity, Oxidative Stress, Pre-Term

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Melatonin drops
Placebo
Sponsored by
Azienda Ospedaliera Universitaria Policlinico "G. Martino"
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Newborn Morbidity

Eligibility Criteria

1 Hour - 6 Hours (Child)All SexesDoes not accept 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.

Sites / Locations

  • Eloisa Gitto

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Melatonin Group

Control Group

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Measurement of AOPP
Evaluation of advanced oxidative protein products (AOPP) in treated group (MEL group) and controls (placebo group)
Measurement of NPBI
Evaluation of non protein binding iron (NPBI) in treated group (MEL group) and controls (placebo group)
Measurement of isoprostanes
Evaluation of isoprostanes in treated group (MEL group) and controls (placebo group)
Measurement of AOPP
Evaluation of advanced oxidative protein products (AOPP) in treated group (MEL group) and controls (placebo group)
Measurement of NPBI
Evaluation of non protein binding iron (NPBI) in treated group (MEL group) and controls (placebo group)
Measurement of isoprostanes
Evaluation of isoprostanes in treated group (MEL group) and controls (placebo group)

Full Information

First Posted
February 16, 2021
Last Updated
March 2, 2021
Sponsor
Azienda Ospedaliera Universitaria Policlinico "G. Martino"
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1. Study Identification

Unique Protocol Identification Number
NCT04785183
Brief Title
Antioxidant Effects of Melatonin in Preterm
Official Title
Early Supplementation of Melatonin in Preterm Newborns: the Effects on Oxidative Stress
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
August 1, 2020 (Actual)
Study Completion Date
September 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Azienda Ospedaliera Universitaria Policlinico "G. Martino"

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Newborn Morbidity, Oxidative Stress, Pre-Term, Melatonin Deficiency

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigator
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Melatonin Group
Arm Type
Experimental
Arm Title
Control Group
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Melatonin drops
Intervention Description
Melatonin oral administration
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Oral 5% glucose
Primary Outcome Measure Information:
Title
Measurement of the melatonin concentration
Description
Analysis of melatonin concentration in treated group (MEL group) and controls (placebo group)
Time Frame
All participants will be evaluated at 24 hours of life
Title
Measurement of the melatonin concentration
Description
Analysis of melatonin concentration in treated group (MEL group) and controls (placebo group)
Time Frame
All participants will be evaluated at 48 hours of life
Secondary Outcome Measure Information:
Title
Measurement of AOPP
Description
Evaluation of advanced oxidative protein products (AOPP) in treated group (MEL group) and controls (placebo group)
Time Frame
All participants will be evaluated at 24 hours of life
Title
Measurement of NPBI
Description
Evaluation of non protein binding iron (NPBI) in treated group (MEL group) and controls (placebo group)
Time Frame
All participants will be evaluated at 24 hours of life
Title
Measurement of isoprostanes
Description
Evaluation of isoprostanes in treated group (MEL group) and controls (placebo group)
Time Frame
All participants will be evaluated at 24 hours of life
Title
Measurement of AOPP
Description
Evaluation of advanced oxidative protein products (AOPP) in treated group (MEL group) and controls (placebo group)
Time Frame
All participants will be evaluated at 48 hours of life
Title
Measurement of NPBI
Description
Evaluation of non protein binding iron (NPBI) in treated group (MEL group) and controls (placebo group)
Time Frame
All participants will be evaluated at 48 hours of life
Title
Measurement of isoprostanes
Description
Evaluation of isoprostanes in treated group (MEL group) and controls (placebo group)
Time Frame
All participants will be evaluated at 48 hours of life
Other Pre-specified Outcome Measures:
Title
Evaluation of the free radical diseases of prematurity occurence
Description
Evaluation of the occurrence of intraventricular haemorrhage (IVH), necrotizing enterocolitis (NEC), retinopathy of prematurity (ROP) and bronchopulmonary dysplasia (BPD)
Time Frame
At 3 months of life

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Hour
Maximum Age & Unit of Time
6 Hours
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Eloisa Gitto
City
Messina
Country
Italy

12. IPD Sharing Statement

Learn more about this trial

Antioxidant Effects of Melatonin in Preterm

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