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

Ain Shams University90 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Preterm Infant Feeding Intolerance Necrotizing Enterocolitis

Interventions

Melatonin 20 mgDRUG

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 treatmentDRUG

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

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (1)

Ain Shams University Pediatrics Department

Cairo, Abbasia, Egypt

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 2 weeks

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.