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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.
Archives of Disease in Childhood. Fetal and Neonatal Edition
|January 15, 2017
Summary
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.
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