Preterm InfantPhase 4NCT04304807
Effect of Melatonin on Feeding Intolerance and Incidence of Necrotizing Enterocolitis in Preterm Infants
A Phase 4 study testing Melatonin 20 mg and Traditional antibiotic treatment in people with Preterm Infant and Feeding Intolerance, run by Ain Shams University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Preterm Infant, Feeding Intolerance, Necrotizing Enterocolitis
- What is being tested?
- Melatonin 20 mg and Traditional antibiotic treatment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 24 Dec 2018to 31 Dec 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Preterm infants (<37 weeks of gestation)
- Evidence of feeding intolerance
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Being tested
- Melatonin 20 mg, Traditional antibiotic treatment
- Medical subject headings
- Premature Birth, Enterocolitis, Necrotizing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Melatonin 20 mgDrug
Also called Melatonin treatment
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
Also called Conventional treatment
Traditional antibiotic treatment was given to both groups with feeding intolerance according to treatment protocols by neonatal intensive care units of Ain Shams University
| Study group | Role | What they receive |
|---|---|---|
| Group I | Experimental | Forty five preterm infants with signs of feeding intolerance who received 20 mg of melatonin treatment in addition to traditional antibiotic treatment. Receives: Drug: Melatonin 20 mg |
| Group II | Sham comparator | Forty five preterm infants with signs of feeding intolerance who received traditional antibiotic treatment only. Receives: Drug: Traditional antibiotic treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2020
- Study start24 Dec 2018
- Primary completion20 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm InfantStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mona Mostafa El-Gammall, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04304807
- Sponsor's protocol ID
- PediatricsASU
- Status last verified
- Mar 2020
- First submitted
- 9 Mar 2020
- Last updated
- 11 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study protocol and informed consent form will be available upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Melatonin on Feeding Intolerance and Incidence of Necrotizing Enterocolitis in Preterm Infants
- ClinicalTrials.gov ID
- NCT04304807
- Acronym / sponsor ID
- PediatricsASU
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 24 Dec 2018 (actual)
- Primary completion
- 20 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 11 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I | Experimental | Drug: Melatonin 20 mgForty five preterm infants with signs of feeding intolerance who received 20 mg of melatonin treatment in addition to traditional antibiotic treatment. |
| Group II | Sham comparator | Drug: Traditional antibiotic treatmentForty five preterm infants with signs of feeding intolerance who received traditional antibiotic treatment only. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Preterm infants (<37 weeks of gestation)
- Evidence of feeding intolerance
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Melatonin 20 mgAlso: Melatonin treatmentMelatonin 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. | Drug | Group I |
| Traditional antibiotic treatmentAlso: Conventional treatmentTraditional antibiotic treatment was given to both groups with feeding intolerance according to treatment protocols by neonatal intensive care units of Ain Shams University | Drug | Group II |
Primary outcome
Melatonin as an antioxidant and free radical scavenger in feeding intolerance in preterm infants
Time frame: 3 days
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
Time frame: 1 week
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
Time frame: 2 weeks
Preterm infants with feeding intolerance were observed for the time needed to reach full enteral intake.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2020.
- Individual participant dataSharing planned: Yes. Study protocol and informed consent form will be available upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Melatonin 20 mg and Traditional antibiotic treatment in people with Preterm Infant and Feeding Intolerance, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Melatonin as an antioxidant and free radical scavenger in feeding intolerance in preterm infants (time frame: 3 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2020.