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Prophylactic propranolol for prevention of ROP and visual outcome at 1 year (PreROP trial)
Kishore Pratap Sanghvi1, Nandkishor S Kabra2, Phalguni Padhi2
1Department of Pediatrics and Neonatology, Jaslok Hospital and Research Centre, Mumbai, India.
Insights
Prophylactic propranolol showed a trend toward reducing retinopathy of prematurity (ROP) incidence and treatment needs in preterm infants. However, these findings were not statistically significant, warranting further investigation into ROP prevention strategies.
Area of Science:
- Neonatal Medicine
- Ophthalmology
- Pharmacology
Background:
- Retinopathy of prematurity (ROP) is a significant cause of visual impairment in preterm infants.
- Early intervention strategies are crucial for preventing ROP and its long-term consequences.
- The role of prophylactic medications in ROP prevention requires further elucidation.
Purpose of the Study:
- To assess the efficacy of prophylactic propranolol in preventing ROP in preterm neonates.
- To evaluate the impact of propranolol on ROP-related treatments and visual outcomes at corrected age.
- To determine the safety profile of prophylactic propranolol in this vulnerable population.
Main Methods:
- A randomized, double-blind, placebo-controlled trial was conducted in two Level III NICUs.
- 109 preterm infants (≤32 weeks gestational age) received either propranolol prophylaxis or a placebo.
- Outcomes included ROP incidence, need for laser or anti-VEGF therapy, and visual acuity at 12 months corrected age.
Main Results:
- Propranolol prophylaxis demonstrated a decreasing trend in ROP incidence (56.8% vs. 68.6%) and need for laser therapy (21.56% vs. 31.37%).
- Trends favoring propranolol were observed for anti-VEGF treatment (3.92% vs. 15.68%) and visual outcomes, though not statistically significant.
- No significant complications due to propranolol were reported.
Conclusions:
- Prophylactic propranolol at 1 mg/kg/day showed a non-significant trend towards reducing ROP incidence and treatment requirements.
- While not statistically significant, the observed trends suggest a potential benefit of propranolol in ROP prevention.
- Further research is needed to confirm these findings and optimize prophylactic strategies for ROP.
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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