Evaluating the effect of Melatonin in treatment of necrotizing enterocolitis

Evaluating the effectiveness of Melatonin in treatment of necrotizing enterocolitis in preterm neonates

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20250908067173N1

Enrollment

Registered

2025-09-20

Start date

2025-10-07

Completion date

Unknown

Last updated

2025-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Necrotizing Enterocolitis. Stage 1 necrotizing enterocolitis in newborn

Interventions

Intervention 1: Intervention group: Ami-vital melatonin drops - which contain 2.5 mg of melatonin per 1 cc - were administered to the patient orally at a dose of 0.3 mg per kilogram of the infant's bo

Eligibility

Sex/Gender

All

Age

1 Days to 1 Months

Inclusion criteria

Inclusion criteria: Gestational age less than 37 weeks (premature neonate) Evidence of feeding intolerance (abdominal distension and/or more than two episodes of vomiting containing milk or bile or blood in 24 hours and/or more than two episodes of clear blood in the stool in 24 hours)

Exclusion criteria

Exclusion criteria: Gestational age greater than 37 weeks The presence of major congenital anomalies in the newborn (which may threaten her life) History of taking probiotics Parental disapproval

Design outcomes

Primary

Measure	Time frame
Abdominal Distention. Timepoint: At the beginning of the study (before the start of the intervention) and 7, 14 days after the start of the intervention. Method of measurement: Patient record & NICU nursing sheet.;Bloody stool. Timepoint: At the beginning of the study (before the start of the intervention) and 7, 14 days after the start of the intervention. Method of measurement: Patient record & NICU nursing sheet.;Feeding intolerance. Timepoint: At the beginning of the study (before the start of the intervention) and 7, 14 days after the start of the intervention. Method of measurement: Patient record & NICU nursing sheet.;Hyponatremia. Timepoint: At the beginning of the study (before the start of the intervention) and 7, 14 days after the start of the intervention. Method of measurement: Lab test.;Thrombocytopenia. Timepoint: At the beginning of the study (before the start of the intervention) and 7, 14 days after the start of the intervention. Method of measurement: Lab test.;Metabolic acidosis. Timepoint: At the beginning of the study (before the start of the intervention) and 7, 14 days after the start of the intervention. Method of measurement: Lab test.;Radiological signs of stages 2 and 3 of necrotizing enterocolitis. Timepoint: At the beginning of the study (before the start of the intervention) and 7, 14 days after the start of the intervention. Method of measurement: Abdominal X Ray.	—

Measure

Time frame

Abdominal Distention. Timepoint: At the beginning of the study (before the start of the intervention) and 7, 14 days after the start of the intervention. Method of measurement: Patient record & NICU nursing sheet.;Bloody stool. Timepoint: At the beginning of the study (before the start of the intervention) and 7, 14 days after the start of the intervention. Method of measurement: Patient record & NICU nursing sheet.;Feeding intolerance. Timepoint: At the beginning of the study (before the start of the intervention) and 7, 14 days after the start of the intervention. Method of measurement: Patient record & NICU nursing sheet.;Hyponatremia. Timepoint: At the beginning of the study (before the start of the intervention) and 7, 14 days after the start of the intervention. Method of measurement: Lab test.;Thrombocytopenia. Timepoint: At the beginning of the study (before the start of the intervention) and 7, 14 days after the start of the intervention. Method of measurement: Lab test.;Metabolic acidosis. Timepoint: At the beginning of the study (before the start of the intervention) and 7, 14 days after the start of the intervention. Method of measurement: Lab test.;Radiological signs of stages 2 and 3 of necrotizing enterocolitis. Timepoint: At the beginning of the study (before the start of the intervention) and 7, 14 days after the start of the intervention. Method of measurement: Abdominal X Ray.

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Secondary

Measure	Time frame
Performing bowel resection surgery. Timepoint: 14 days after the start of the intervention. Method of measurement: Procedure description sheet in the patient record.;Length of stay in the NICU. Timepoint: 14 days after the start of the intervention. Method of measurement: Patient record.;Time required to achieve full enteral feeding. Timepoint: 14 days after the start of the intervention. Method of measurement: Patient record.;Mortality from Necrotizing Enterocolitis. Timepoint: 14 days after the start of the intervention. Method of measurement: Death certificate sheet in the patient's record.	—

Measure

Time frame

Performing bowel resection surgery. Timepoint: 14 days after the start of the intervention. Method of measurement: Procedure description sheet in the patient record.;Length of stay in the NICU. Timepoint: 14 days after the start of the intervention. Method of measurement: Patient record.;Time required to achieve full enteral feeding. Timepoint: 14 days after the start of the intervention. Method of measurement: Patient record.;Mortality from Necrotizing Enterocolitis. Timepoint: 14 days after the start of the intervention. Method of measurement: Death certificate sheet in the patient's record.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactShahryar Azari

Shahid Beheshti University of Medical Sciences

shahryarazari99@yahoo.com+98 21 6640 8976

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026