TY - JOUR
T1 - Propranolol 0.1% eye micro-drops in newborns with retinopathy of prematurity
T2 - A pilot clinical trial
AU - Filippi, Luca
AU - Cavallaro, Giacomo
AU - Bagnoli, Paola
AU - Dal Monte, Massimo
AU - Fiorini, Patrizio
AU - Berti, Elettra
AU - Padrini, Letizia
AU - Donzelli, Gianpaolo
AU - Araimo, Gabriella
AU - Cristofori, Gloria
AU - Fumagalli, Monica
AU - La Marca, Giancarlo
AU - Della Bona, Maria Luisa
AU - Pasqualetti, Roberta
AU - Fortunato, Pina
AU - Osnaghi, Silvia
AU - Tomasini, Barbara
AU - Vanni, Maurizio
AU - Calvani, Anna Maria
AU - Milani, Silvano
AU - Cortinovis, Ivan
AU - Pugi, Alessandra
AU - Agosti, Massimo
AU - Mosca, Fabio
PY - 2017/2/1
Y1 - 2017/2/1
N2 - Background:Oral propranolol reduces retinopathy of prematurity (ROP) progression, although not safely. This study evaluated safety and efficacy of propranolol eye micro-drops in preterm newborns with ROP.Methods:A multicenter open-label trial, planned according to the Simon optimal two-stage design, was performed to analyze safety and efficacy of propranolol micro-drops in newborns with stage 2 ROP. To this end, hemodynamic and respiratory parameters were monitored, and blood samples were collected weekly, for 3 wk. Propranolol plasma levels were also monitored. The progression of the disease was evaluated with serial ophthalmologic examinations.Results:Twenty-three newborns were enrolled. Since the fourth of the first 19 newborns enrolled in the first stage of the study showed a progression to stage 2 or 3 with plus, the second stage was prematurely discontinued. Even though the objective to complete the second stage was not achieved, the percentage of ROP progression (26%) was similar to that obtained previously with oral propranolol administration. However, no adverse effects were observed and propranolol plasma levels were significantly lower than those measured after oral administration.Conclusion:Propranolol 0.1% eye micro-drops are well tolerated, but not sufficiently effective. Further studies are required to identify the optimal dose and administration schedule.
AB - Background:Oral propranolol reduces retinopathy of prematurity (ROP) progression, although not safely. This study evaluated safety and efficacy of propranolol eye micro-drops in preterm newborns with ROP.Methods:A multicenter open-label trial, planned according to the Simon optimal two-stage design, was performed to analyze safety and efficacy of propranolol micro-drops in newborns with stage 2 ROP. To this end, hemodynamic and respiratory parameters were monitored, and blood samples were collected weekly, for 3 wk. Propranolol plasma levels were also monitored. The progression of the disease was evaluated with serial ophthalmologic examinations.Results:Twenty-three newborns were enrolled. Since the fourth of the first 19 newborns enrolled in the first stage of the study showed a progression to stage 2 or 3 with plus, the second stage was prematurely discontinued. Even though the objective to complete the second stage was not achieved, the percentage of ROP progression (26%) was similar to that obtained previously with oral propranolol administration. However, no adverse effects were observed and propranolol plasma levels were significantly lower than those measured after oral administration.Conclusion:Propranolol 0.1% eye micro-drops are well tolerated, but not sufficiently effective. Further studies are required to identify the optimal dose and administration schedule.
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U2 - 10.1038/pr.2016.230
DO - 10.1038/pr.2016.230
M3 - Article
AN - SCOPUS:85012937991
VL - 81
SP - 307
EP - 314
JO - Pediatric Research
JF - Pediatric Research
SN - 0031-3998
IS - 2
ER -