Antioxidant Effects of Melatonin in Preterm

Study Overview
=================
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.

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

Conditions
-----------------
Newborn Morbidity, Oxidative Stress, Pre-Term, Melatonin Deficiency

Intervention / Treatment
-----------------
* Dietary Supplement: Melatonin drops
* Other: Placebo


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 1 Hour
Maximum Age: 6 Hours

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Melatonin Group<br> | Dietary Supplement: Melatonin drops<br>* Melatonin oral administration<br>|
| Placebo Comparator: Control Group<br> | Other: Placebo<br>* Oral 5% glucose<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 |