drugset / Trial / NCT05033639

Efficacy Of Oral Melatonin To Prevent Necrotizing Enterocolitis

NCT05033639

RandomizedParallel-groupQuadruple-blindPrevention

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.

Timeline

Start
2021-03-01
Primary completion
2021-12-31
Completion
2021-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Melatonin Small molecule 6 mg Oral