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

Ain Shams University

Status and phase: Completed; Phase 4

Conditions: Necrotizing Enterocolitis; Preterm Infant; Feeding Intolerance

Treatments: Drug: Melatonin 20 mg; Drug: Traditional antibiotic treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT04304807

PediatricsASU

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 2 patient groups

Group I

Experimental group

Description:

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

Treatment:

Drug: Melatonin 20 mg

Group II

Sham Comparator group

Description:

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

Treatment:

Drug: Traditional antibiotic treatment