Efficacy Of Oral Melatonin To Prevent Necrotizing Enterocolitis

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.

Study Overview

• Status: Completed
• Conditions: Necrotizing Enterocolitis
• Intervention / Treatment: Drug: Melatonin 6 MG; Other: Breast Milk

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 Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Navid P Roodaki; Phone Number: +63 917 309 3931; Email: navidroodaki2391@gmail.com

Study Locations

• Philippines
  • LA Union
    • San Fernando, LA Union, Philippines, 2500
      • Ilocos Training and Regional Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 8 months (Child)
• Accepts Healthy Volunteers: No

Description

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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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: 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.
Placebo Comparator: 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.	Other: Breast Milk; Naturally occurring milk from the mother of the infant.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Prematurity at Training and Regional Medical Center	Clinical Profiles Of Preterm Infants Born In Ilocos Training and Regional Medical Center	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.	5 MONTHS
Number of Patients Who Developed Pneumatosis intestinalis after Melatonin 6mg Tablet Prophylaxis	Absence of Clinical And Radiologic Findings Diagnostic of Necrotizing Enterocolitis.	5 Months
Number of Patients Who Developed Sentinel Loops after Melatonin 6mg Tablet Prophylaxis	Absence of Clinical And Radiologic Findings Diagnostic of Necrotizing Enterocolitis.	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.	5 Months
Number Of Hospital Days Among Preterm Infants Admitted at Ilocos Training and Regional Medical Center	Efficacy of Melatonin Oral Prophylaxis	5 Months
Number Of Days Before Oral FeedingAmong Preterm Infants Admitted at Ilocos Training and Regional Medical Center	Efficacy of Melatonin Oral Prophylaxis	5 motnhs

Collaborators and Investigators

• Sponsor: Ilocos Training and Regional Medical Center
• Investigators: Study Director: Daisy Evangeline C Garcia, MD, Ilocos Training and Regional Medical Center; Principal Investigator: Navid P Roodaki, MD, ITRMC

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2021
• Primary Completion (Actual): December 31, 2021
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: August 22, 2021
• First Submitted That Met QC Criteria: September 2, 2021
• First Posted (Actual): September 5, 2021

Study Record Updates

• Last Update Posted (Actual): October 4, 2023
• Last Update Submitted That Met QC Criteria: October 3, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Enterocolitis; Enterocolitis, Necrotizing; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Protective Agents; Antioxidants; Melatonin
• Other Study ID Numbers: ITRMC-REC-2021-008

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: due to the data privacy act of the philippines, individual data cannot be shared however the completed data will be shared

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No