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The effect of melatonin in the prevention of retinopathy of prematurity

The effect of melatonin in the prevention of retinopathy of prematurity in preterm neonates

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20211226053528N2
Enrollment
60
Registered
2022-09-21
Start date
2021-12-22
Completion date
Unknown
Last updated
2022-11-21

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

Conditions

Retinopathy of Prematurity. Retinopathy of prematurity

Interventions

Intervention 1: Intervention group: Babies receive melatonin softgel (Nutralab under license of Canada) daily at dosage of 3 mg/ kg/day until 37 weeks. Intervention 2: Control group: This group of neo

Sponsors

Iran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Days to 7 Days

Inclusion criteria

Inclusion criteria: Parents satisfaction to participate in the study Premature newborns under 34 weeks Lack of congenital anomalies Lack of genetic disorder, metabolic disorder or suffering from TORCH Lack of intraventricular hemorrhage (grade 3 and 4)

Exclusion criteria

Exclusion criteria: Intraventricular hemorrhage (grade 3 and 4) during patients follow up Incidence of gastrointestinal complications such as NEC during treatment if it is not possible to take the medicine orally. Taking less than 14 days of melatonin

Design outcomes

Primary

MeasureTime frame
Stopping of abnormal blood vessels formation in the retina. Timepoint: End of 37 weeks and end of 44 weeks. Method of measurement: Examination by retina fellowship and with ophthalmoscope.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactHamid Khalilian

Iran University of Medical Sciences

hkhalilian1410@gmail.com+98 21 2304 6253

Outcome results

None listed

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