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Prophylactic propranolol for prevention of ROP and visual outcome at 1 year (PreROP trial)
  1. Kishore Pratap Sanghvi1,
  2. Nandkishor S Kabra2,
  3. Phalguni Padhi2,
  4. Umesh Singh1,
  5. Swarup Kumar Dash2,
  6. Bhupendra S Avasthi2
  1. 1 Department of Pediatrics and Neonatology, Jaslok Hospital and Research Centre, Mumbai, India
  2. 2 Department of Pediatrics and Neonatology, Surya Children's Hospital, Mumbai, India
  1. Correspondence to Dr Kishore Pratap Sanghvi, Department of Pediatrics and Neonatology, Jaslok Hospital and Research Centre, MA, Sonkamal, 220-C, Walkeshwar Road, Mumbai 400006, India; kpsanghvi{at}hotmail.com

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.

Design Randomised double blind placebo controlled trial, parallel group nrolment with allocation ratio of 1:1.

Settings Two level III neonatal intensive care units.

Participants 109 preterm neonates of ≤32 weeks of gestation with postnatal age ≤8 days old.

Intervention 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 group infants received a placebo.

Outcome measures 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.

Trial registration number CTRI/2013/11/004131.

  • Preterm
  • ROP
  • Propranolol
  • Retinopathy of prematurity
  • Anti-VEGF

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Footnotes

  • Contributors KPS: Original concept and design, acquisition of data, analysis and interpretation of data, drafting and evaluation of manuscript, patient management. NSK: Design, acquisition of data, analysis and interpretation of data, drafting and evaluation of manuscript, patient management. PP: Review of literature, management of patients, data collection. US: Review of literature, management of patients, data collection. SKD: Review of literature, management of patients, data collection. BSA: Review of manuscript, management of patients. The final manuscript was approved by all the authors.

  • Competing interests None declared.

  • Ethics approval Jaslok Hospital and Research Centre, Surya Hospital.

  • Provenance and peer review Not commissioned; externally peer reviewed.

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