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Evaluation of the oral Melatonin effects on the incidence, severity and results of Retinopathy of Prematurity in preterm infants, a randomized clinical trial-Imam Khomeini Hospital complex-Valiasr,Tehran

Evaluation of the oral Melatonin effects on the incidence, severity and results of Retinopathy of Prematurity in preterm infants, a randomized clinical trial-Imam Khomeini Hospital complex-Valiasr,Tehran

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20240703062313N1
Enrollment
50
Registered
2024-12-08
Start date
2024-11-21
Completion date
Unknown
Last updated
2025-01-08

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

Conditions

Investigating the preventive effect of a drug intervention on an important and vital complication in premature babies (retinopathy of prematurity). Retinopathy of prematurity

Interventions

Intervention 1: Intervention group: melatonin oral medication with a dose of 3 mg per kg, which will be started during the first 72 hours of life, orally once a day, at 11:00 PM for 10 consecutive day

Sponsors

Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 3 Days

Inclusion criteria

Inclusion criteria: Obtaining informed consent from parents to enter the study Gestational age less than 34 weeks or weight less than two kilograms Ability to take oral medication Absence of metabolic or genetic disease Absence of kidney and liver diseases

Exclusion criteria

Exclusion criteria: Lack of informed parental consent in entering the study Gestational age more than 34 weeks Digestive obstructions Failure to take medication regularly

Design outcomes

Primary

MeasureTime frame
Retinopathy of prematurity. Timepoint: Fourth to sixth week of life. Method of measurement: Ophthalmological examination.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactZiba Mossayebi

Tehran University of Medical Sciences

Imamhospital@tums.ac.ir+98 21 6119 0000

Outcome results

None listed

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