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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Preterm Infant, Feeding Intolerance, Necrotizing Enterocolitis

Intervention / Treatment
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* Drug: Melatonin 20 mg
* Drug: Traditional antibiotic treatment


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group I<br>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<br>* 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.<br>* Other names: Melatonin treatment;|
| Sham Comparator: Group II<br>Forty five preterm infants with signs of feeding intolerance who received traditional antibiotic treatment only. | Drug: Traditional antibiotic treatment<br>* Traditional antibiotic treatment was given to both groups with feeding intolerance according to treatment protocols by neonatal intensive care units of Ain Shams University<br>* Other names: Conventional treatment;|

What is the study measuring?
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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 |