Archives of disease in childhood. Fetal and neonatal edition · 2017
Prophylactic propranolol for prevention of ROP and visual outcome at 1 year (PreROP trial).
СтатьяРандомизированное исследованиеНазвание и аннотация: Перевод в очереди
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Sanghvi Kishore Pratap, Kabra Nandkishor S, Padhi Phalguni, Singh Umesh, Dash Swarup Kumar, Avasthi Bhupendra S
Аннотация
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.
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.