Melatonin Deficiency, Newborn Morbidity, Oxidative Stress, Pre-Term
Conditions
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.
Interventions
DIETARY_SUPPLEMENTMelatonin drops
Melatonin oral administration
OTHERPlacebo
Oral 5% glucose
Sponsors
Azienda Ospedaliera Universitaria Policlinico G. Martino
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
1 Hours to 6 Hours
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Measurement of the melatonin concentration | All participants will be evaluated at 24 hours of life | Analysis of melatonin concentration in treated group (MEL group) and controls (placebo group) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Measurement of AOPP | 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) |
| Measurement of NPBI | 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) |
| Measurement of isoprostanes | All participants will be evaluated at 24 hours of life | Evaluation of isoprostanes in treated group (MEL group) and controls (placebo group) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of the free radical diseases of prematurity occurence | At 3 months of life | Evaluation of the occurrence of intraventricular haemorrhage (IVH), necrotizing enterocolitis (NEC), retinopathy of prematurity (ROP) and bronchopulmonary dysplasia (BPD) |
Countries
Italy
Outcome results
None listed