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

Phase 4

Completed

• Conditions: Necrotizing Enterocolitis; Preterm Infant; Feeding Intolerance
• Interventions: Drug: Traditional antibiotic treatment; Drug: Melatonin 20 mg

• Registration Number: NCT04304807
• Lead Sponsor: Ain Shams University

Brief 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.

Study Timeline

• Study Start: 2018-12-24
• Primary Completion: 2019-12-20
• Study Completion: 2019-12-31
• Status Verified: 2020-03
• Study First Submitted: 2020-03-09
• Study First Submitted QC: 2020-03-10
• Last Update Submitted: 2020-03-10
• Study First Posted: 2020-03-11
• Last Update Posted: 2020-03-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• Preterm infants (<37 weeks of gestation)
• Evidence of feeding intolerance

Read More

Exclusion Criteria

• Infants with hypoxic ischemic encephalopathy
• Infants on nothing per os
• Infants with high oxygen needs wither on invasive or non-invasive mechanical ventilation
• Major congenital anomalies
• Intracranial hemorrhage
• Respiratory distress syndrome

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group II	Traditional antibiotic treatment	Forty five preterm infants with signs of feeding intolerance who received traditional antibiotic treatment only.
Group I	Melatonin 20 mg	Forty five preterm infants with signs of feeding intolerance who received 20 mg of melatonin treatment in addition to traditional antibiotic treatment.

Primary Outcome Measures

Name	Time	Method
Melatonin as an antioxidant and free radical scavenger in feeding intolerance in preterm infants	3 days	Melatonin efficacy in treatment of oxidative stress in preterm infants with feeding intolerance was assessed by measuring level of tumor necrosis factor- alpha.
Melatonin efficacy in reducing incidence of necrotizing enterocolitis in preterm infants	1 week	Melatonin efficacy in reducing incidence of necrotizing enterocolitis by radiological criteria: abdominal ultrasound showing pneumatosis intestinalis.
Effect of melatonin on time needed to reach full enteral intake in preterm infants with feeding intolerance	2 weeks	Preterm infants with feeding intolerance were observed for the time needed to reach full enteral intake.

Trial Locations

Locations (1)

Ain Shams University Pediatrics Department; 🇪🇬 Cairo, Abbasia, Egypt