title: Prophylactic propranolol for prevention of ROP and visual outcome at 1 year (PreROP trial).
abstract: OBJECTIVE
  To evaluate the role of prophylactic propranolol in the prevention of retinopathy of prematurity (ROP) in infants ≤32 weeks of gestational age and their visual outcome at 1 year of corrected gestational age.
  
  
  METHODS
  Randomised double blind placebo controlled trial, parallel group nrolment with allocation ratio of 1:1.
  
  
  METHODS
  Two level III neonatal intensive care units.
  
  
  METHODS
  109 preterm neonates of ≤32 weeks of gestation with postnatal age ≤8 days old.
  
  
  METHODS
  Study group:Infants with gestational age between 26 and 32 weeks were started on propranolol prophylaxis (0.5 mg/kg/dose every 12 hours) on seventh completed day of life, till a corrected gestational age of 37 weeks or complete vascularisation of retina whichever was later.Control groupinfants received a placebo.
  
  
  METHODS
  Primary: ROP of all grades;Secondary: evaluation of complications due to propranolol, ROP needing treatment with laser and/or antivascular endothelial growth factor (anti-VEGF) and visual outcome at 12 months corrected age.
  
  
  RESULTS
  Prophylactic propranolol in the prescribed dose of 1 mg/kg/day showed a decreasing trend in the incidence of ROP (56.8% vs 68.6%; p=0.39), need for laser therapy (21.56% vs 31.37%; p=0.37), treatment with anti-VEGF (3.92% vs 15.68%; p=0.09) or visual outcomes at 1 year in the study and control groups, respectively, though these reductions were not statistically significant. Decreasing trends favouring propranolol in all other ROP-related outcomes were also noted in the study group.
  
  
  CONCLUSIONS
  Prophylactic propranolol in the prescribed dose of 1 mg/kg/day showed a decreasing trend in all outcomes of ROP though statistically not significant.
  
  
  BACKGROUND
  CTRI/2013/11/004131.
authors.affiliation: Department of Pediatrics and Neonatology, Jaslok Hospital and Research Centre, Mumbai, India.
authors.forename: Kishore Pratap
authors.initials: KP
authors.lastname: Sanghvi
authors.affiliation: Department of Pediatrics and Neonatology, Surya Children's Hospital, Mumbai, India.
authors.forename: Nandkishor S
authors.initials: NS
authors.lastname: Kabra
authors.affiliation: Department of Pediatrics and Neonatology, Surya Children's Hospital, Mumbai, India.
authors.forename: Phalguni
authors.initials: P
authors.lastname: Padhi
authors.affiliation: Department of Pediatrics and Neonatology, Jaslok Hospital and Research Centre, Mumbai, India.
authors.forename: Umesh
authors.initials: U
authors.lastname: Singh
authors.affiliation: Department of Pediatrics and Neonatology, Surya Children's Hospital, Mumbai, India.
authors.forename: Swarup Kumar
authors.initials: SK
authors.lastname: Dash
authors.affiliation: Department of Pediatrics and Neonatology, Surya Children's Hospital, Mumbai, India.
authors.forename: Bhupendra S
authors.initials: BS
authors.lastname: Avasthi
mesh_terms: D004311:Double-Blind Method; D004363:Drug Utilization / Q000706:statistics & numerical data; D005260:Female; D005865:Gestational Age; D006801:Humans; D007194:India / Q000453:epidemiology; D007223:Infant; D007231:Infant, Newborn; D007234:Infant, Premature; D007363:Intensive Care Units, Neonatal; D053685:Laser Therapy / Q000706:statistics & numerical data; D008297:Male; D011433:Propranolol / Q000008:administration & dosage*; D012178:Retinopathy of Prematurity / Q000453:epidemiology / Q000517:prevention & control*; D042442:Vascular Endothelial Growth Factors / Q000037:antagonists & inhibitors; D014665:Vasodilator Agents / Q000008:administration & dosage*
chemical_list: D042442:Vascular Endothelial Growth Factors; D014665:Vasodilator Agents; D011433:Propranolol
keywords: Anti-VEGF; Preterm; Propranolol; ROP; Retinopathy of prematurity