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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Melatonin Group | Experimental |
| |
| Control Group | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Melatonin drops | Dietary Supplement | Melatonin oral administration |
| |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eloisa Gitto | Messina | Italy |
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| Placebo |
| Other |
Oral 5% glucose |
|
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 |
| D000091642 | Urogenital Diseases |