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

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 greater in premature neonates of Kamali Hospital in Karaj in 2022 and 2023

The clinical trial has three parallel groups (two intervention groups with propranolol and timolol eye drops) and a control group, double-blind, randomized on 75 patients (25 patients in each group), phase 2. In this study, allocation Randomization will be done using permuted block balance randomization technique and STATA software will be used .

This study will be done as a clinical trial in Kamali Karaj Teaching Hospital in 2022-2023. According to the sample size formula, 75 people will be included in the study and the patients will be divided into three groups. An oral propranolol group and timolol eye drops group and usual treatment. . The study will be done in a double blind way so that the doctor and Nurses are aware of patients, but ophthalmologists and epidemiologists are not aware.

Inclusion criteria: 1.Gestational age less than 34 weeks 2. Premature infants aged 26 to 34 weeks who underwent eye examination from the fourth to the twelfth week of birth and it was determined that 2 stage ROP and above are Exclusion Criteria: 1. Infants with congenital or acquired cardiac anomalies 2. Renal failure 3. Cerebral hemorrhage 4. ROP stage 1 5. Unstable hemodynamics 6. Sepsis

Patients will be divided into three groups. One group will receive oral propranolol 0.5 dose/kg/mg every 8 hours in addition to the standard treatment, and the other group will receive timolol eye drops 0.5 drops twice a day, and the other group will receive the usual treatment.

Progression rate of stage 3 retinopathy of prematurity in stage 2 retinopathy

In this study, random allocation for placement in Each group will receive the intervention at the standard time using the block balance permuted randomization technique . According to these blocks considered in this study, there will be six blocks. using software STATA will generate a chain of random numbers from 1 to 6 until the desired sample size is reached. Given that the total number of states for Receiving medicine in blocks of 6 is 6 if the number produced is more than 6, regardless of the next number. will be produced.Preparation of random allocation sequences of drug groups and placing them in sealed envelopes (confidential) and numbering with a 5-digit serial number by a third party who is not involved in the design of the study All envelopes will have a 5-digit serial number that will be opened immediately after the patients enter the study. And the patients will be divided into three groups.

Participating parents and participants do not know in which group are located. Eye examinations done by only one ophthalmologist. The doctor will take care and the ophthalmologist will not inform which group the infant is in