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IRCT20100520003982N1 IRCT 2019-01-23 Yazd University of Medical Sciences Effect of propranolol in retinopathy ROP Effect of oral propranolol in retinopathy of prematurity 2017-07-07 anticipated 60 Complete https://irct.ir/trial/36438 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Other, Purpose: Treatment, Randomization description: Randomization was done using a random number table . To use the random numbers table, we considered the table numbers from the left to read the table numbers. Then, by placing a number and moving in the left direction, the odd numbers for control and the pair numbers were considered for intervention, Blinding description: The doctor examines newborns without knowing the grouping of them . Also, the Data analyzer did not know the groups and identified them as groups A and B. 3 Retinopathy of prematurity. Intervention 1: Intervention group: Oral propranolol (prilol 10 from OLIDARU): Start with dose of 0.25 mg / kg / dday for two days , then take 0.5mg / kg / day every 12 hours until the patient needs laser therapy or intra-ocular injection, or healing is complete without an aggressive treatment. Intervention 2: Control group: does not receive any drugs. Ophthalmic examinations (indirect ophthalmoscopy) were performed on a weekly basis from day 28 of birth for all infants admitted to the neonatal intensive care unit.In the absence of improvement in the baby, aggressive therapies including laser therapy and Bevacizumab injections were performed. 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 No more information.
public Akram Mirjalili
Paknezhad Bulvar
Yazd Iran (Islamic Republic of) 8916976745 +98 35 3726 4881 dr.akrammirjalili@yahoo.com Yazd University of Medical Sciences scientific Doctor Mahmood Noori Shadkam
Shahid Sadoghi Hospital , Shahid Ghandi ST , Atlasi SQ , Safaieh
YAZD Iran (Islamic Republic of) 8915887857 +98 35 3811 3277 Noorishadkam@ssu.ac.ir Yazd University of Medical Sciences Iran (Islamic Republic of) Preterm infants less than 1500 gr Preterm infants with gestational age greater than 26 weeks and less than 32 weeks Preterm infants with retinopathy grade I and II ROP Preterm infants admitted to NICU. 182 days 224 days Both Congenital malformation cardiovascular problems except Patent Ductus Arteriosus (PAD) active sepsis Congenital infections (TORCH) Intraventricular hemorrhage (IVH) Grade II and III H35.1 Retinopathy of prematurity Treatment - Drugs Other Intervention group: Oral propranolol (prilol 10 from OLIDARU): Start with dose of 0.25 mg / kg / dday for two days , then take 0.5mg / kg / day every 12 hours until the patient needs laser therapy or intra-ocular injection, or healing is complete without an aggressive treatment. Control group: does not receive any drugs. Ophthalmic examinations (indirect ophthalmoscopy) were performed on a weekly basis from day 28 of birth for all infants admitted to the neonatal intensive care unit.In the absence of improvement in the baby, aggressive therapies including laser therapy and Bevacizumab injections were performed. Retinopathy process. Timepoint: On the 28th day after birth (before entering the study), every week until the end of study. Method of measurement: Indirect ophthalmoscopy. Yazd University of Medical Sciences Approved 2017-07-07 Ethics Committee of Shahid Sadoughi University of Medical Sciences, Yazd Alam Square,Safayeh Yazd Yazd Iran (Islamic Republic of)