A Phase 1/2 interventional study of Melatonin 6 MG and Breast Milk in Necrotizing Enterocolitis, sponsored by Ilocos Training and Regional Medical Center. Completed at 1 site in Philippines. Open to participants aged 28 Weeks to 36 Weeks. Per ClinicalTrials.gov, last updated 2024-06-20.
Sponsored by Ilocos Training and Regional Medical Center · Phase 1/2, Interventional, and Prevention
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.
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.
228 studies on the registry are indexed under Enterocolitis, Necrotizing; 44 are open to participants now.
This study's enrollment of 100 is close to the median of 103 across 127 interventional studies indexed under Enterocolitis, Necrotizing.
Browse Enterocolitis, Necrotizing studies →Ilocos Training and Regional Medical Center is the lead sponsor of 4 studies on the registry; none are open to participants now.
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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.
Exclusion Criteria:
Meconium Stained Preterm infants
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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
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
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.
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.
Time frame: 5 MONTHS
Incidence of Prematurity at Training and Regional Medical Center
Clinical Profiles Of Preterm Infants Born In Ilocos Training and Regional Medical Center
Time frame: 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.
Time frame: 5 MONTHS
Number of Patients Who Developed Pneumatosis intestinalis after Melatonin 6mg Tablet Prophylaxis
Absence of Clinical And Radiologic Findings Diagnostic of Necrotizing Enterocolitis.
Time frame: 5 Months
Number of Patients Who Developed Sentinel Loops after Melatonin 6mg Tablet Prophylaxis
Absence of Clinical And Radiologic Findings Diagnostic of Necrotizing Enterocolitis.
Time frame: 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.
Time frame: 5 Months
Number Of Hospital Days Among Preterm Infants Admitted at Ilocos Training and Regional Medical Center
Efficacy of Melatonin Oral Prophylaxis
Time frame: 5 Months
Number Of Days Before Oral FeedingAmong Preterm Infants Admitted at Ilocos Training and Regional Medical Center
Efficacy of Melatonin Oral Prophylaxis
Time frame: 5 motnhs
Plan to share: No — due to the data privacy act of the philippines, individual data cannot be shared however the completed data will be shared
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This study is completed, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Melatonin
Ilocos Training and Regional Medical Center