Back to resultsEffect of Melatonin on Feeding Intolerance and Incidence of Necrotizing Enterocolitis in Preterm Infants
Primary Purpose
Preterm Infant, Feeding Intolerance, Necrotizing Enterocolitis
Status
Completed
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Melatonin 20 mg
Traditional antibiotic treatment
Sponsored by
About this trial
This is an interventional treatment trial for Preterm Infant
Eligibility Criteria
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
Sites / Locations
- Ain Shams University Pediatrics Department
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Group I
Group II
Arm Description
Forty five preterm infants with signs of feeding intolerance who received 20 mg of melatonin treatment in addition to traditional antibiotic treatment.
Forty five preterm infants with signs of feeding intolerance who received traditional antibiotic treatment only.
Outcomes
Primary Outcome Measures
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.
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.
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04304807
Brief Title
Effect of Melatonin on Feeding Intolerance and Incidence of Necrotizing Enterocolitis in Preterm Infants
Official Title
Effect of Melatonin on Feeding Intolerance and Incidence of Necrotizing Enterocolitis in Preterm Infants
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
December 24, 2018 (Actual)
Primary Completion Date
December 20, 2019 (Actual)
Study Completion Date
December 31, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterm Infant, Feeding Intolerance, Necrotizing Enterocolitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group I
Arm Type
Experimental
Arm Description
Forty five preterm infants with signs of feeding intolerance who received 20 mg of melatonin treatment in addition to traditional antibiotic treatment.
Arm Title
Group II
Arm Type
Sham Comparator
Arm Description
Forty five preterm infants with signs of feeding intolerance who received traditional antibiotic treatment only.
Intervention Type
Drug
Intervention Name(s)
Melatonin 20 mg
Other Intervention Name(s)
Melatonin treatment
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Traditional antibiotic treatment
Other Intervention Name(s)
Conventional treatment
Intervention Description
Traditional antibiotic treatment was given to both groups with feeding intolerance according to treatment protocols by neonatal intensive care units of Ain Shams University
Primary Outcome Measure Information:
Title
Melatonin as an antioxidant and free radical scavenger in feeding intolerance in preterm infants
Description
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
Title
Melatonin efficacy in reducing incidence of necrotizing enterocolitis in preterm infants
Description
Melatonin efficacy in reducing incidence of necrotizing enterocolitis by radiological criteria: abdominal ultrasound showing pneumatosis intestinalis.
Time Frame
1 week
Title
Effect of melatonin on time needed to reach full enteral intake in preterm infants with feeding intolerance
Description
Preterm infants with feeding intolerance were observed for the time needed to reach full enteral intake.
Time Frame
2 weeks
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Ain Shams University Pediatrics Department
City
Cairo
State/Province
Abbasia
ZIP/Postal Code
11511
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Study protocol and informed consent form will be available upon reasonable request.
IPD Sharing Time Frame
Within 6 months after finishing the study
Learn more about this trial
Effect of Melatonin on Feeding Intolerance and Incidence of Necrotizing Enterocolitis in Preterm Infants
We'll reach out to this number within 24 hrs