Efficacy Of Oral Melatonin To Prevent Necrotizing Enterocolitis

NCT ID: NCT05033639

Last Updated: 2024-06-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-01
• Study Completion Date: 2021-12-31

Brief 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. 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.

Conditions

Necrotizing Enterocolitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Treatment Group

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.

Group Type: EXPERIMENTAL

Melatonin 6 MG

Intervention Type: DRUG

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.

Control Group

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.

Group Type: PLACEBO_COMPARATOR

Breast Milk

Intervention Type: OTHER

Naturally occurring milk from the mother of the infant.

Interventions

Melatonin 6 MG

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.

Intervention Type: DRUG

Breast Milk

Naturally occurring milk from the mother of the infant.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

1. Preterm infants more than 1 day of life.

2. Preterm infants diagnosed with NEC

3. 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.

4. Preterm infants that could not be fed through oral gastric tube due to a secondary problem.

5. Preterm infants with other comorbidities such as asphyxia, congenital anomalies, and other inherited disorders.

6. Meconium Stained Preterm infants

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• Minimum Eligible Age: 28 Weeks
• Maximum Eligible Age: 36 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vayu Global Foundation

UNKNOWN

Sponsor Role: collaborator

Ilocos Training and Regional Medical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

Navid Roodaki

Pediatric Chief Resident

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Daisy Evangeline C Garcia, MD

Role: STUDY_DIRECTOR

Ilocos Training and Regional Medical Center

Navid P Roodaki, MD

Role: PRINCIPAL_INVESTIGATOR

ITRMC

Locations

Ilocos Training and Regional Medical Center

San Fernando City, LA Union, Philippines

Countries

Philippines

Other Identifiers

ITRMC-REC-2021-008

Identifier Type: -

Identifier Source: org_study_id