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Investigation of beta-blockers in preventing the exacerbation of retinopathy of prematurity

Investigation of the oral (propranolol) and topical beta-blocker (Timolol eye drop) drugs in preventing the exacerbation of retinopathy of prematurity of stage 2 and above in premature neonates

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT20230526058300N1
Enrollment
75
Registered
2023-12-30
Start date
2023-12-22
Completion date
Unknown
Last updated
2024-01-22

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, stage 2

Interventions

Intervention 1: Intervention group: they receive oral propranolol 0.5 dose/kg/mg every 8 hours in addition to the standard treatment. We dissolve the propranolol tablet in the form of powder in 5% dex

Sponsors

Karaj University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
189 Days to 224 Days

Inclusion criteria

Inclusion criteria: Gestational age less than 34 weeks Premature infants between 26 weeks and 34 weeks, who underwent ophthalmic examination from the fourth to the twelfth week of birth and it was determined that they have stage 2 ROP and above.

Exclusion criteria

Exclusion criteria: Infants with congenital or acquired cardiac anomalies ROP stage 1 Unstable hemodynamic

Design outcomes

Primary

MeasureTime frame
Determining the progression rate of retinopathy of prematurity 3 stage in babies with retinopathy 2 stage. Timepoint: weekly examination by ophthalmologist until discharge. Method of measurement: Retcam imaging system II.

Secondary

MeasureTime frame
The rate of complete recovery of retinopathy of prematurity in infants with stage 2 retinopathy. Timepoint: Weekly examination by Ophthalmologist. Method of measurement: Retcam imaging system II.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr Hani Milani

Karaj University of Medical Sciences

hanimilani@gamil.com+98 26 3226 6851

Outcome results

None listed

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