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Completed

NCT Number: NCT04304807

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.

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Key information

Conditions

Preterm Infant Digestive System Diseases Enterocolitis Enterocolitis, Necrotizing Feeding Intolerance Female Urogenital Diseases and Pregnancy Complications Gastroenteritis Gastrointestinal Diseases Intestinal Diseases Necrotizing Enterocolitis Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Ain Shams University Pediatrics Department

Cairo, Abbasia, 11511, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Melatonin treatment

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

Other names: Conventional treatment

Primary outcomes

  1. Melatonin as an antioxidant and free radical scavenger in feeding intolerance in preterm infants

    Time frame: 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.

  2. Melatonin efficacy in reducing incidence of necrotizing enterocolitis in preterm infants

    Time frame: 1 week

    Melatonin efficacy in reducing incidence of necrotizing enterocolitis by radiological criteria: abdominal ultrasound showing pneumatosis intestinalis.

  3. Effect of melatonin on time needed to reach full enteral intake in preterm infants with feeding intolerance

    Time frame: 2 weeks

    Preterm infants with feeding intolerance were observed for the time needed to reach full enteral intake.

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Mar 11, 2020
Registry last updated
Mar 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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