Necrotizing EnterocolitisPhase 1/2NCT05033639
Efficacy Of Oral Melatonin To Prevent Necrotizing Enterocolitis
A Phase 1/2 study testing Melatonin 6 MG and Breast Milk in people with Necrotizing Enterocolitis, run by Ilocos Training and Regional Medical Center at 1 site in Philippines.
Trial summary
Prematurity is still one of the primary causes of death in children under 5. 1-2. According to the WHO, 60% of all preterm births occur in Asia, with the Philippines accounting for around 348,900 every year. 3. Necrotizing enterocolitis is one of the fatal complications (NEC) 3, 4. Read more about this study
- Who is it for?
- Ages 28 to 36 weeks
- Conditions the study is for
- Necrotizing Enterocolitis
- What is being tested?
- Melatonin 6 MG and Breast Milk
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 sitePhilippines
- Study dates
- 1 Mar 2021to 31 Dec 2021
- Phase
- Phase 1/2
- 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 28 to 36 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 1. Newborn with a pediatric age of less than 37 weeks categorized very preterm (28 to 32 weeks) and late preterm (32 to 36weeks) by the World Health Organization weighing not more than 1500.
- 2. Preterm infants admitted at the Neonatal Intensive care unit of Ilocos Training Regional and Medical Center not more than 24 hours of age.
- 3. Preterm infants with orogastric tube in place. 4. Preterm infants with no other condition other than prematurity and respiratory distress syndrome.
- 5. Preterm infant with an Apgar score of more than 6 in the first minute of life.
Who cannot join
- Preterm infants more than 1 day of life.
- Preterm infants diagnosed with NEC
- Preterm infants who is born to a mother of who considered as a minor (<18 years old) and is not married to the father of the unborn child.
- Preterm infants that could not be fed through oral gastric tube due to a secondary problem.
- Preterm infants with other comorbidities such as asphyxia, congenital anomalies, and other inherited disorders.
- Meconium Stained Preterm infants
- -
Trial locations and contacts
1 site in 1 country.
Philippines1 site
Ilocos Training and Regional Medical Center
San Fernando City, LA Union, 2500
About this study
Official title: Efficacy Of Oral Melatonin To Prevent Necrotizing Enterocolitis Among Preterm Infants In A Tertiary Level Hospital In The Philippines: A Randomized Control Trial
Prematurity is still one of the primary causes of death in children under 5. 1-2. According to the WHO, 60% of all preterm births occur in Asia, with the Philippines accounting for around 348,900 every year. 3. Necrotizing enterocolitis is one of the fatal complications (NEC) 3, 4. Preterm newborns weighing 1500 grams or less are considered high risk. 5-6.
Melatonin is one chemical that may help prevent NEC. Melatonin is an endogenous indolamine derived from serotonin. It is a ubiquitous molecule that is crucial to the body's physiologic function. Melatonin, also known as N-acetyl-5-methoxytryptamine, is an immunomodulator, antioxidant, anti-inflammatory, and free radical scavenger7-10.
It is a naturally occurring chemical that is simply replenished. With this in mind, the researcher wants to see if providing high dose melatonin to premature babies can prevent NEC.
Read the detailed description
Prematurity remains as one of the leading causes of mortality among children less than 5 years old1-2. The World Health Organization that 60 percent of all preterm births around the world occurs in Asian countries and roughly 348,900 births occur each year in the Philippines3. One complication that contribute to the high mortality is necrotizing enterocolitis (NEC)1, 3-4. High risk population include preterm infants weighing 1500 grams and lower with inverse correlation to the patient's weight5-6.
One compound that could be used to prevent NEC is melatonin. Melatonin is an endogenously produced indolamine principally synthesized in the pineal gland from serotonin. It is described as a ubiquitous molecule which plays a vital role in the physiologic function of the body. Melatonin, also known as N-acetyl-5-methoxytryptamine which has a a) immunomodulator; b) free radical scavenger; c) prevention of oxidative stress and d) anti-inflammatory7-10.
It is a naturally occurring substance and it would just be supplemented to increase its levels. With all this in mind, the researcher would like to determine if giving high dose melatonin among preterm neonates could prevent NEC among high risk population.
- Conditions
- Necrotizing Enterocolitis
- Being tested
- Melatonin 6 MG, Breast Milk
- Medical subject headings
- Enterocolitis, Necrotizing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Melatonin 6 MGDrug
Melatonin is an endogenously produced indolamine principally synthesized in the pineal gland from serotonin. It is described as a ubiquitous molecule which plays a vital role in the physiologic function of the body. Melatonin, also known as N-acetyl-5-methoxytryptamine which has a a) immunomodulator; b) free radical scavenger; c) prevention of oxidative stress and d) anti-inflammatory7-10.
Breast MilkOther
Naturally occurring milk from the mother of the infant.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | Other than the Standard Management of preterm infant, treatment group A infants will receive 6 mg tablet dissolved in 5 ml breastmilk via oral gastric tube administered once a day at 10 pm. Receives: Drug: Melatonin 6 MG |
| Control Group | Placebo comparator | Human breast milk 5ml would be used as the placebo in this study. It would be indistinguishable from the treatment group as this will also be the diluent used. Receives: Other: Breast Milk |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number Of Preterm Infants Who Developed Necrotizing Enterocolits After Melatonin 6mg Tablet Prophylaxis
effectiveness of melatonin in preventing NEC among preterm infants with a birthweight of </ = 1500 kg at Ilocos Training and Regional Medical Center.
Measured: 5 MONTHS
Secondary outcomes (7)
Incidence of Prematurity at Training and Regional Medical Center
Clinical Profiles Of Preterm Infants Born In Ilocos Training and Regional Medical Center
Measured: 5 MONTHS
Number of Patients Who Developed Abnormal Gas Pattern with Dilated Bowel Loops after Melatonin 6mg Tablet Prophylaxis
Absence of Clinical And Radiologic Findings Diagnostic of Necrotizing Enterocolitis.
Measured: 5 MONTHS
Number of Patients Who Developed Pneumatosis intestinalis after Melatonin 6mg Tablet Prophylaxis
Absence of Clinical And Radiologic Findings Diagnostic of Necrotizing Enterocolitis.
Measured: 5 Months
Number of Patients Who Developed Sentinel Loops after Melatonin 6mg Tablet Prophylaxis
Absence of Clinical And Radiologic Findings Diagnostic of Necrotizing Enterocolitis.
Measured: 5 Months
Number of Patients Who Developed Portal Venous Gas after Melatonin 6mg Tablet Prophylaxis
Absence of Clinical And Radiologic Findings Diagnostic of Necrotizing Enterocolitis.
Measured: 5 Months
Number Of Hospital Days Among Preterm Infants Admitted at Ilocos Training and Regional Medical Center
Efficacy of Melatonin Oral Prophylaxis
Measured: 5 Months
Number Of Days Before Oral FeedingAmong Preterm Infants Admitted at Ilocos Training and Regional Medical Center
Efficacy of Melatonin Oral Prophylaxis
Measured: 5 motnhs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2021
- Study start1 Mar 2021
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Necrotizing EnterocolitisStudies of the same condition, open and under way.
- 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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a double-blind Randomized Control trial where melatonin would be the interventions given to preterm infants admitted at the Neonatal Intensive Care Unit of Ilocos Training and Regional Medical Center.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ilocos Training and Regional Medical Center
- Sponsor type
- Other government
- Collaborators
- Vayu Global Foundation
- Responsible party
- Principal investigator, Navid Roodaki, Ilocos Training and Regional Medical Center
- Investigators
- Daisy Evangeline C Garcia, MD, Study director, Ilocos Training and Regional Medical CenterNavid P Roodaki, MD, Principal investigator, ITRMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05033639
- Sponsor's protocol ID
- ITRMC-REC-2021-008
- Status last verified
- Jun 2024
- First submitted
- 22 Aug 2021
- Last updated
- 20 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: due to the data privacy act of the philippines, individual data cannot be shared however the completed data will be shared
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy Of Oral Melatonin To Prevent Necrotizing Enterocolitis Among Preterm Infants In A Tertiary Level Hospital In The Philippines: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT05033639
- Acronym / sponsor ID
- ITRMC-REC-2021-008
- Conditions
- Necrotizing Enterocolitis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Ilocos Training and Regional Medical CenterOther government
- Collaborators
- Vayu Global Foundation
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 5 Sep 2021 (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.
Prematurity is still one of the primary causes of death in children under 5. 1-2. According to the WHO, 60% of all preterm births occur in Asia, with the Philippines accounting for around 348,900 every year. 3. Necrotizing enterocolitis is one of the fatal complications (NEC) 3, 4. Preterm newborns weighing 1500 grams or less are considered high risk. 5-6.
Melatonin is one chemical that may help prevent NEC. Melatonin is an endogenous indolamine derived from serotonin. It is a ubiquitous molecule that is crucial to the body's physiologic function. Melatonin, also known as N-acetyl-5-methoxytryptamine, is an immunomodulator, antioxidant, anti-inflammatory, and free radical scavenger7-10.
It is a naturally occurring chemical that is simply replenished. With this in mind, the researcher wants to see if providing high dose melatonin to premature babies can prevent NEC.
Detailed description
Prematurity remains as one of the leading causes of mortality among children less than 5 years old1-2. The World Health Organization that 60 percent of all preterm births around the world occurs in Asian countries and roughly 348,900 births occur each year in the Philippines3. One complication that contribute to the high mortality is necrotizing enterocolitis (NEC)1, 3-4. High risk population include preterm infants weighing 1500 grams and lower with inverse correlation to the patient's weight5-6.
One compound that could be used to prevent NEC is melatonin. Melatonin is an endogenously produced indolamine principally synthesized in the pineal gland from serotonin. It is described as a ubiquitous molecule which plays a vital role in the physiologic function of the body. Melatonin, also known as N-acetyl-5-methoxytryptamine which has a a) immunomodulator; b) free radical scavenger; c) prevention of oxidative stress and d) anti-inflammatory7-10.
It is a naturally occurring substance and it would just be supplemented to increase its levels. With all this in mind, the researcher would like to determine if giving high dose melatonin among preterm neonates could prevent NEC among high risk population.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a double-blind Randomized Control trial where melatonin would be the interventions given to preterm infants admitted at the Neonatal Intensive Care Unit of Ilocos Training and Regional Medical Center.
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Drug: Melatonin 6 MGOther than the Standard Management of preterm infant, treatment group A infants will receive 6 mg tablet dissolved in 5 ml breastmilk via oral gastric tube administered once a day at 10 pm. |
| Control Group | Placebo comparator | Other: Breast MilkHuman breast milk 5ml would be used as the placebo in this study. It would be indistinguishable from the treatment group as this will also be the diluent used. |
Who may qualify
- Ages
- 28 to 36 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 1. Newborn with a pediatric age of less than 37 weeks categorized very preterm (28 to 32 weeks) and late preterm (32 to 36weeks) by the World Health Organization weighing not more than 1500.
- 2. Preterm infants admitted at the Neonatal Intensive care unit of Ilocos Training Regional and Medical Center not more than 24 hours of age.
- 3. Preterm infants with orogastric tube in place. 4. Preterm infants with no other condition other than prematurity and respiratory distress syndrome.
- 5. Preterm infant with an Apgar score of more than 6 in the first minute of life.
Key exclusion criteria (7 listed)
- Preterm infants more than 1 day of life.
- Preterm infants diagnosed with NEC
- Preterm infants who is born to a mother of who considered as a minor (<18 years old) and is not married to the father of the unborn child.
- Preterm infants that could not be fed through oral gastric tube due to a secondary problem.
- Preterm infants with other comorbidities such as asphyxia, congenital anomalies, and other inherited disorders.
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 6 MGMelatonin is an endogenously produced indolamine principally synthesized in the pineal gland from serotonin. It is described as a ubiquitous molecule which plays a vital role in the physiologic function of the body. Melatonin, also known as N-acetyl-5-methoxytryptamine which has a a) immunomodulator; b) free radical scavenger; c) prevention of oxidative stress and d) anti-inflammatory7-10. | Drug | Treatment Group |
| Breast MilkNaturally occurring milk from the mother of the infant. | Other | Control Group |
Primary outcome
Number Of Preterm Infants Who Developed Necrotizing Enterocolits After Melatonin 6mg Tablet Prophylaxis
Time frame: 5 MONTHS
effectiveness of melatonin in preventing NEC among preterm infants with a birthweight of </ = 1500 kg at Ilocos Training and Regional Medical Center.
7 secondary outcomes
Incidence of Prematurity at Training and Regional Medical Center
Time frame: 5 MONTHS
Number of Patients Who Developed Abnormal Gas Pattern with Dilated Bowel Loops after Melatonin 6mg Tablet Prophylaxis
Time frame: 5 MONTHS
Number of Patients Who Developed Pneumatosis intestinalis after Melatonin 6mg Tablet Prophylaxis
Time frame: 5 Months
Number of Patients Who Developed Sentinel Loops after Melatonin 6mg Tablet Prophylaxis
Time frame: 5 Months
Number of Patients Who Developed Portal Venous Gas after Melatonin 6mg Tablet Prophylaxis
Time frame: 5 Months
Number Of Hospital Days Among Preterm Infants Admitted at Ilocos Training and Regional Medical Center
Time frame: 5 Months
Number Of Days Before Oral FeedingAmong Preterm Infants Admitted at Ilocos Training and Regional Medical Center
Time frame: 5 motnhs
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 20 Jun 2024.
- Individual participant dataSharing planned: No. due to the data privacy act of the philippines, individual data cannot be shared however the completed data will be shared
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RecruitingObservational study
Multidimensional Dynamic Early Warning System for Neonatal Necrotizing Enterocolitis: A Multicenter Clinical Study
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Recruiting
Fecal Microbiota Transplantation (FMT) as a Prophylaxis of Necrotizing Enterocolitis (NEC) - Clinical Study
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Active, not recruitingObservational study
Early Predictors of Necrotizing Enterocolitis in Neonates
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Effects of Enteral Feeding Regimens on NEC, Mortality, and Neurodevelopment in Very Preterm Infants
Very Preterm Infant, Necrotizing Enterocolitis (NEC)
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.
Daisy Evangeline C Garcia, MD study director
Ilocos Training and Regional Medical Center
Navid P Roodaki, MD principal investigator
ITRMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Melatonin 6 MG and Breast Milk in people with Necrotizing Enterocolitis, run by Ilocos Training and Regional Medical Center at 1 site in Philippines.
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 4 inclusion and 7 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 20 Jun 2024. 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 Philippines. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Number Of Preterm Infants Who Developed Necrotizing Enterocolits After Melatonin 6mg Tablet Prophylaxis (time frame: 5 MONTHS). 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 20 Jun 2024.