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Clinical Trial Summary

Assesses the efficacy of melatonin in treatment of feeding intolerance in preterm infants, the time needed to reach full enteral intake, the incidence of necrotizing enterocolitis and measures the level of tumor necrosis factor-alpha as a marker of oxidative stress.


Clinical Trial Description

This is a prospective study held on ninety preterm infants in Ain Shams University neonatal intensive care units. All enrolled neonates were suffering from feeding intolerance in the form of abdominal distension, gastric residuals or bloody stools. The first group of forty five infants were given melatonin in addition to traditional antibiotic treatment. The second group of forty five infants were given traditional antibiotic treatment only. Both groups were followed up clinically as regards improvement of clinical signs of feeding intolerance and laboratory results till they reached full enteral intake. Both groups were compared as regards incidence of necrotizing enterocolitis and level of tumor necrosis factor-alpha after 72 hours of starting treatment as a marker of oxidative stress. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04304807
Study type Interventional
Source Ain Shams University
Contact
Status Completed
Phase Phase 4
Start date December 24, 2018
Completion date December 31, 2019

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