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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. 1Department of Pediatrics and Neonatology, Jaslok Hospital and Research Centre, Mumbai, India
  2. 2Department 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.

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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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