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IRCT20230526058300N1 IRCT 2023-12-30 Karaj University of Medical Sciences 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 2023-12-22 anticipated 75 Complete https://irct.ir/trial/73980 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: 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, Blinding description: 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. 2 Retinopathy of prematurity. 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% dextrose and give it to the baby after eating milk. Intervention 2: Intervention group: Timolol eye drops 0.5 drops twice a day. Intervention 3: Control group: Receiving the usual treatment for ROP means patient follow-up until complete recovery and regression of ROP or the need for intraocular injection of Avastin, surgery, laser therapy. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no more information
public Dr Hani Milani
Shahid Beheshti
Karaj Iran (Islamic Republic of) 3198764653 +98 26 3226 6851 hanimilani@gamil.com Karaj University of Medical Sciences scientific Dr Hani Milani
Shahid Beheshti
Karaj Iran (Islamic Republic of) 3198764653 +98 26 3226 6851 hanimilani@gamil.com Karaj University of Medical Sciences Iran (Islamic Republic of) 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. 189 days 224 days Both Infants with congenital or acquired cardiac anomalies ROP stage 1 Unstable hemodynamic H35.13 Retinopathy of prematurity, stage 2 Treatment - Drugs Treatment - Drugs Treatment - Other 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% dextrose and give it to the baby after eating milk. Intervention group: Timolol eye drops 0.5 drops twice a day Control group: Receiving the usual treatment for ROP means patient follow-up until complete recovery and regression of ROP or the need for intraocular injection of Avastin, surgery, laser therapy 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. 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. Karaj University of Medical Sciences Approved 2023-12-02 Ethics committee of Alborz university of medical Sceiences 45 metri Golshahr Karaj Alborz Iran (Islamic Republic of)