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IRCT20100512003915N21 IRCT 2018-11-12 Tabriz University of Medical Sciences Oral propranolol and retinopathy of prematurity The efficacy of oral Propranolol in the treatment of the retinopathy of prematurity 2018-04-23 anticipated 72 Complete https://irct.ir/trial/31406 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Seventy two preterm infants who met inclusion criteria and the diagnosis of retinopathy of prematurity confirms by ophthalmologist in eye examination, will randomly allocate in control and intervention groups by random numbers generated by random number generator. Ophthalmologist that performs eye examination and a nurse who records patients data are blind about patients groups and their received drugs, Blinding description: Eye examiner ophthalmologist is not involved in medical management of neonates and isn't aware about patients received drugs. patients allocate to groups with respect to propranolol with coding and the nurse who records patients' data is blind to their groups. 2-3 Retinopathy of prematurity. Intervention 1: Intervention group: We start treatment with oral propranolol ( Osve, Iran) 0.5 mg/kg every 8 hr after detection of retinopathy of prematurity in first eye examination. Drug administration will continue till corrected gestational age of 38 weeks. Intervention 2: Control group receive routine care for preterm infants. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Mina Hosseini
NICU, Al Zahra hospital, South Artesh St.
Tabriz Iran (Islamic Republic of) 5136688449 +98 41 3553 9161 Ehsasatme2000@yahoo.com Tabriz University of Medical Sciences scientific Mina Hosseini
NICU, Alzahra hospital, South Artesh St.
Tabriz Iran (Islamic Republic of) 5136688449 +98 41 3553 9161 Ehsasatme2000@yahoo.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Preterm infants with gestational age of less than 30 weeks Birth weight less than 1250 grams Stage 1 or 2 for retinopathy of prematurity 28 days 120 days Both Infants with congenital anomalies Congenital or acquired cardiovascular disease in neonate Acute renal failure Severe intra-ventricular hemorrhage H35.1 Retinopathy of prematurity Treatment - Drugs Treatment - Other Intervention group: We start treatment with oral propranolol ( Osve, Iran) 0.5 mg/kg every 8 hr after detection of retinopathy of prematurity in first eye examination. Drug administration will continue till corrected gestational age of 38 weeks. Control group receive routine care for preterm infants. The need to intervention (laser therapy or Avastin administration) in retinopathy of prematurity. Timepoint: Corrected gestational age 38 weeks (gestational age plus age after birth in weeks). Method of measurement: Ophthalmoscopic eye examination and performing laser therapy or Avastin administration. Tabriz University of Medical Sciences Approved 2018-04-23 Ethic Committee of Tabriz University of Medical Sciences Central University Building, Golghasht St. Tabriz East Azarbaijan Iran (Islamic Republic of)