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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
50
Melatonin oral administration
Oral 5% glucose
Eloisa Gitto
Messina, Italy
Measurement of the melatonin concentration
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
Measurement of the melatonin concentration
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
Measurement of AOPP
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
Measurement of NPBI
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
Measurement of isoprostanes
Evaluation of isoprostanes in treated group (MEL group) and controls (placebo group)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: All participants will be evaluated at 48 hours of life
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