Ignite Creation Date:
2024-05-06 @ 3:51 PM
Last Modification Date:
2024-10-26 @ 1:58 PM
Study NCT ID:
NCT04785183
Status:
COMPLETED
Last Update Posted:
2021-03-05
First Post:
2021-02-16
Brief Title:
Antioxidant Effects of Melatonin in Preterm
Sponsor:
Azienda Ospedaliera Universitaria Policlinico G Martino
Organization:
Azienda Ospedaliera Universitaria Policlinico G Martino
Study Overview
Official Title:
Early Supplementation of Melatonin in Preterm Newborns the Effects on Oxidative Stress
Status:
COMPLETED
Status Verified Date:
2021-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None