Efficacy Of Oral Melatonin To Prevent Necrotizing Enterocolitis
Condition: Necrotizing Enterocolitis
MeSH terms: Enterocolitis; Enterocolitis, Necrotizing
Study type: Interventional
Phase: Phase 1/Phase 2

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.
    

Intervention name(s): Melatonin 6 MG; Breast Milk
Intervention type(s): Drug; Other
Intervention description(s): 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.; Naturally occurring milk from the mother of the infant.
Intervention MeSH terms: Melatonin
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 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.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention