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

Necrotizing Enterocolitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04304807
• Other study ID #: PediatricsASU
• Status: Completed
• Phase: Phase 4
• Start date: December 24, 2018
• Est. completion date: December 31, 2019

Study information

• Verified date: March 2020
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: December 31, 2019
• Est. primary completion date: December 20, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Preterm infants (<37 weeks of gestation)

• Evidence of feeding intolerance

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

Related Conditions & MeSH terms

• Enterocolitis
• Enterocolitis, Necrotizing
• Feeding Intolerance
• Necrotizing Enterocolitis
• Premature Birth
• Preterm Infant

Intervention

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.
• 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

Locations

Country	Name	City	State
Egypt	Ain Shams University Pediatrics Department	Cairo	Abbasia

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

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