Efficacy Of Oral Melatonin To Prevent Necrotizing Enterocolitis

NCT05033639 | Completed Phase 1 DMC

• 1 other identifier: ITRMC-REC-2021-008
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Necrotizing Enterocolitis

Outcome Measures

Primary Outcomes (1)

• 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.

  5 MONTHS

Secondary Outcomes (7)

• Incidence of Prematurity at Training and Regional Medical Center

  5 MONTHS

• Number of Patients Who Developed Abnormal Gas Pattern with Dilated Bowel Loops after Melatonin 6mg Tablet Prophylaxis

  5 MONTHS

• Number of Patients Who Developed Pneumatosis intestinalis after Melatonin 6mg Tablet Prophylaxis

  5 Months

• Number of Patients Who Developed Sentinel Loops after Melatonin 6mg Tablet Prophylaxis

  5 Months

• Number of Patients Who Developed Portal Venous Gas after Melatonin 6mg Tablet Prophylaxis

  5 Months

Study Arms (2)

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.

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.

Other: Breast Milk

Interventions

Melatonin 6 MG 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.

Treatment Group

Breast Milk OTHER

Naturally occurring milk from the mother of the infant.

Control Group

Eligibility Criteria

• Age: 28 Weeks - 36 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• \. 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.
• \. Preterm infants admitted at the Neonatal Intensive care unit of Ilocos Training Regional and Medical Center not more than 24 hours of age.
• \. Preterm infants with orogastric tube in place. 4. Preterm infants with no other condition other than prematurity and respiratory distress syndrome.
• \. Preterm infant with an Apgar score of more than 6 in the first minute of life.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ilocos Training and Regional Medical Center: lead
• Vayu Global Foundation: collaborator

Study Sites (1)

Ilocos Training and Regional Medical Center

San Fernando City, LA Union, 2500, Philippines

Location

MeSH Terms

Conditions

Enterocolitis, Necrotizing

Interventions

Melatonin; Milk, Human

Condition Hierarchy (Ancestors)

Enterocolitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Milk; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Dairy Products; Food; Food and Beverages

Study Officials

• Daisy Evangeline C Garcia, MD

  Ilocos Training and Regional Medical Center

  STUDY DIRECTOR

• Navid P Roodaki, MD

  ITRMC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Once the mother is admitted for labor, she or the father will be asked to sign consent. However, if the mother was admitted as an emergency delivery, the parents would be ask immediately after delivery. No one would know what group the patient will be. Enrolled infants will be randomized by a 1:1 block scheme to provide a comparable subject in each group.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pediatric Chief Resident

Model Details: 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.

Study Record Dates

• First Submitted: August 22, 2021
• First Posted: September 5, 2021
• Study Start: March 1, 2021
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: June 20, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

PH (1)