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

NCT ID: NCT04304807

Last Updated: 2020-03-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-24
• Study Completion Date: 2019-12-31

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.

Conditions

Preterm Infant; Feeding Intolerance; Necrotizing Enterocolitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group I

Forty five preterm infants with signs of feeding intolerance who received 20 mg of melatonin treatment in addition to traditional antibiotic treatment.

Group Type: EXPERIMENTAL

Melatonin 20 mg

Intervention Type: DRUG

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.

Group II

Forty five preterm infants with signs of feeding intolerance who received traditional antibiotic treatment only.

Group Type: SHAM_COMPARATOR

Traditional antibiotic treatment

Intervention Type: DRUG

Traditional antibiotic treatment was given to both groups with feeding intolerance according to treatment protocols by neonatal intensive care units of Ain Shams University

Interventions

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.

Intervention Type: 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

Intervention Type: DRUG

Other Intervention Names

Melatonin treatment; Conventional treatment

Eligibility Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Mona Mostafa El-Gammall

Resident of pediatrics and neonatology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ain Shams University Pediatrics Department

Cairo, Abbasia, Egypt

Countries

Egypt

Other Identifiers

PediatricsASU

Identifier Type: -

Identifier Source: org_study_id