Prophylactic propranolol for prevention of ROP and visual outcome at 1 year (PreROP trial).

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

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. infants received a placebo.

OUTCOME MEASURES

: ROP of all grades; : 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.