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

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.

Study Overview

• Status: Completed
• Conditions: Necrotizing Enterocolitis; Preterm Infant; Feeding Intolerance
• Intervention / Treatment: Drug: Melatonin 20 mg; Drug: Traditional antibiotic treatment

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 Type: Interventional
• Enrollment (Actual): 90
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Abbasia
    • Cairo, Abbasia, Egypt, 11511
      • Ain Shams University Pediatrics Department

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group I; Forty five preterm infants with signs of feeding intolerance who received 20 mg of melatonin treatment in addition to traditional antibiotic treatment.	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.; Other Names: Melatonin treatment
Sham Comparator: Group II; Forty five preterm infants with signs of feeding intolerance who received traditional antibiotic treatment only.	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; Other Names: Conventional treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): December 24, 2018
• Primary Completion (Actual): December 20, 2019
• Study Completion (Actual): December 31, 2019

Study Registration Dates

• First Submitted: March 9, 2020
• First Submitted That Met QC Criteria: March 10, 2020
• First Posted (Actual): March 11, 2020

Study Record Updates

• Last Update Posted (Actual): March 11, 2020
• Last Update Submitted That Met QC Criteria: March 10, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Premature Birth; Enterocolitis; Enterocolitis, Necrotizing; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Central Nervous System Depressants; Protective Agents; Antioxidants; Melatonin; Anti-Bacterial Agents
• Other Study ID Numbers: PediatricsASU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Study protocol and informed consent form will be available upon reasonable request.
• IPD Sharing Time Frame: Within 6 months after finishing the study
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No