Necrotizing Enterocolitis Clinical Trial
Official title:
Effect of Melatonin on Feeding Intolerance and Incidence of Necrotizing Enterocolitis in Preterm Infants
Verified date | March 2020 |
Source | Ain Shams University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 90 |
Est. completion date | December 31, 2019 |
Est. primary completion date | December 20, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Egypt | Ain Shams University Pediatrics Department | Cairo | Abbasia |
Lead Sponsor | Collaborator |
---|---|
Ain Shams University |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 |
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