NCT04304807

Effect of Melatonin on Feeding Intolerance and Incidence of Necrotizing Enterocolitis in Preterm Infants

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: Ain Shams University · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Preterm Infant
• Feeding Intolerance
• Necrotizing Enterocolitis

Interventions

Type	Name	Description
DRUG	Melatonin 20 mg	Melatonin was given as a total dose of 20 mg via enteral route in two doses of 10 mg each with a 1 hour interval in between.
DRUG	Traditional antibiotic treatment	Traditional antibiotic treatment was given to both groups with feeding intolerance according to treatment protocols by neonatal intensive care units of Ain Shams University

Timeline

• Start date: 2018-12-24
• Primary completion: 2019-12-20
• Completion: 2019-12-31
• First posted: 2020-03-11
• Last updated: 2020-03-11

Locations

1 site across 1 country: Egypt