Prophylactic propranolol for prevention of ROP and visual outcome at 1 year (PreROP trial). Sanghvi K.P., Kabra N.S., Padhi P., Singh U., Dash S.K., & Avasthi B.S. 2017.
Paper abstract bibtex Objective To evaluate the role of prophylactic propranolol in the prevention of retinopathy of prematurity (ROP) in infants \textless32 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 \textless32 weeks of gestation with postnatal age \textless8 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. Copyright © 2017 BMJ Publishing Group Ltd & Royal College of Paediatrics and Child Health.
@misc{sanghvi_k.p._prophylactic_2017,
title = {Prophylactic propranolol for prevention of {ROP} and visual outcome at 1 year ({PreROP} trial)},
url = {http://adc.bmjjournals.com},
abstract = {Objective To evaluate the role of prophylactic propranolol in the prevention of retinopathy of prematurity (ROP) in infants {\textless}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 {\textless}32 weeks of gestation with postnatal age {\textless}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. Copyright © 2017 BMJ Publishing Group Ltd \& Royal College of Paediatrics and Child Health.},
journal = {Archives of Disease in Childhood},
author = {{Sanghvi K.P.} and {Kabra N.S.} and {Padhi P.} and {Singh U.} and {Dash S.K.} and {Avasthi B.S.}},
year = {2017},
keywords = {*propranolol, Neonatal intensive care unit, adverse drug reaction, clinical trial, control group, controlled clinical trial, controlled study, double blind procedure, drug therapy, endogenous compound, gestational age, human, infant, intervention study, low level laser therapy, major clinical study, newborn, normal human, parallel design, placebo, prophylaxis, randomized controlled trial, registration, retina, retrolental fibroplasia, side effect, vascularization, vasculotropin}
}
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{"_id":"uJ5xcmZFjg6TcQfTB","bibbaseid":"sanghvikp-kabrans-padhip-singhu-dashsk-avasthibs-prophylacticpropranololforpreventionofropandvisualoutcomeat1yearpreroptrial-2017","downloads":0,"creationDate":"2017-05-12T20:20:57.748Z","title":"Prophylactic propranolol for prevention of ROP and visual outcome at 1 year (PreROP trial)","author_short":["Sanghvi K.P.","Kabra N.S.","Padhi P.","Singh U.","Dash S.K.","Avasthi B.S."],"year":2017,"bibtype":"misc","biburl":"http://bibbase.org/zotero/gxu917","bibdata":{"bibtype":"misc","type":"misc","title":"Prophylactic propranolol for prevention of ROP and visual outcome at 1 year (PreROP trial)","url":"http://adc.bmjjournals.com","abstract":"Objective To evaluate the role of prophylactic propranolol in the prevention of retinopathy of prematurity (ROP) in infants \\textless32 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 \\textless32 weeks of gestation with postnatal age \\textless8 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. Copyright © 2017 BMJ Publishing Group Ltd & Royal College of Paediatrics and Child Health.","journal":"Archives of Disease in Childhood","author":[{"firstnames":[],"propositions":[],"lastnames":["Sanghvi K.P."],"suffixes":[]},{"firstnames":[],"propositions":[],"lastnames":["Kabra N.S."],"suffixes":[]},{"firstnames":[],"propositions":[],"lastnames":["Padhi P."],"suffixes":[]},{"firstnames":[],"propositions":[],"lastnames":["Singh U."],"suffixes":[]},{"firstnames":[],"propositions":[],"lastnames":["Dash S.K."],"suffixes":[]},{"firstnames":[],"propositions":[],"lastnames":["Avasthi B.S."],"suffixes":[]}],"year":"2017","keywords":"*propranolol, Neonatal intensive care unit, adverse drug reaction, clinical trial, control group, controlled clinical trial, controlled study, double blind procedure, drug therapy, endogenous compound, gestational age, human, infant, intervention study, low level laser therapy, major clinical study, newborn, normal human, parallel design, placebo, prophylaxis, randomized controlled trial, registration, retina, retrolental fibroplasia, side effect, vascularization, vasculotropin","bibtex":"@misc{sanghvi_k.p._prophylactic_2017,\n\ttitle = {Prophylactic propranolol for prevention of {ROP} and visual outcome at 1 year ({PreROP} trial)},\n\turl = {http://adc.bmjjournals.com},\n\tabstract = {Objective To evaluate the role of prophylactic propranolol in the prevention of retinopathy of prematurity (ROP) in infants {\\textless}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 {\\textless}32 weeks of gestation with postnatal age {\\textless}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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