Efficacy Of Oral Melatonin To Prevent Necrotizing Enterocolitis

• Status: Recruiting
• Trial end date: 2021-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ilocos Training and Regional Medical Center
• Treatments: Melatonin

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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