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

NCT04304807 | Completed Phase 4

• 1 other identifier: PediatricsASU
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Preterm Infant; Feeding Intolerance; Necrotizing Enterocolitis

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Group I

EXPERIMENTAL

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

Group II

SHAM COMPARATOR

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

Drug: Traditional antibiotic treatment

Interventions

Melatonin 20 mg 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.

Also known as: Melatonin treatment

Group I

Traditional antibiotic treatment 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

Also known as: Conventional treatment

Group II

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University Pediatrics Department

Cairo, Abbasia, 11511, Egypt

Location

MeSH Terms

Conditions

Premature Birth; Enterocolitis, Necrotizing

Interventions

Melatonin

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Enterocolitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident of pediatrics and neonatology

Study Record Dates

• First Submitted: March 9, 2020
• First Posted: March 11, 2020
• Study Start: December 24, 2018
• Primary Completion: December 20, 2019
• Study Completion: December 31, 2019
• Last Updated: March 11, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Within 6 months after finishing the study

Locations

EG (1)