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Study protocol: safety and efficacy of propranolol 0.2% eye drops in newborns with a precocious stage of retinopathy of prematurity (DROP-ROP-0.2%): a multicenter, open-label, single arm, phase II trial

  • Luca Filippi1Email author,
  • Giacomo Cavallaro2,
  • Elettra Berti1,
  • Letizia Padrini1,
  • Gabriella Araimo2,
  • Giulia Regiroli2,
  • Valentina Bozzetti3,
  • Chiara De Angelis3,
  • Paolo Tagliabue3,
  • Barbara Tomasini4,
  • Giuseppe Buonocore5,
  • Massimo Agosti6,
  • Angela Bossi6,
  • Gaetano Chirico7,
  • Salvatore Aversa7,
  • Roberta Pasqualetti8,
  • Pina Fortunato8,
  • Silvia Osnaghi9,
  • Barbara Cavallotti10,
  • Maurizio Vanni11,
  • Giulia Borsari11,
  • Simone Donati12,
  • Giuseppe Nascimbeni13,
  • Giancarlo la Marca14,
  • Giulia Forni14,
  • Silvano Milani15,
  • Ivan Cortinovis15,
  • Paola Bagnoli16,
  • Massimo Dal Monte16,
  • Anna Maria Calvani17,
  • Alessandra Pugi18,
  • Eduardo Villamor19,
  • Gianpaolo Donzelli1 and
  • Fabio Mosca2
BMC PediatricsBMC series – open, inclusive and trusted201717:165

https://doi.org/10.1186/s12887-017-0923-8

Received: 22 November 2016

Accepted: 5 July 2017

Published: 14 July 2017

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Open Peer Review reports

Pre-publication versions of this article and author comments to reviewers are available by contacting info@biomedcentral.com.

Original Submission
22 Nov 2016 Submitted Original manuscript
10 Mar 2017 Author responded Author comments - Luca Filippi
Resubmission - Version 2
10 Mar 2017 Submitted Manuscript version 2
29 Mar 2017 Reviewed Reviewer Report - Brian William Fleck
20 Apr 2017 Reviewed Reviewer Report - Yannis Paulus
16 May 2017 Author responded Author comments - Luca Filippi
Resubmission - Version 3
16 May 2017 Submitted Manuscript version 3
17 May 2017 Reviewed Reviewer Report - Brian William Fleck
8 Jun 2017 Reviewed Reviewer Report - Yannis Paulus
28 Jun 2017 Author responded Author comments - Luca Filippi
Resubmission - Version 4
28 Jun 2017 Submitted Manuscript version 4
Publishing
5 Jul 2017 Editorially accepted
14 Jul 2017 Article published 10.1186/s12887-017-0923-8

How does Open Peer Review work?

Open peer review is a system where authors know who the reviewers are, and the reviewers know who the authors are. If the manuscript is accepted, the named reviewer reports are published alongside the article. Pre-publication versions of the article and author comments to reviewers are available by contacting info@biomedcentral.com. All previous versions of the manuscript and all author responses to the reviewers are also available.

You can find further information about the peer review system here.

Authors’ Affiliations

(1)
Neonatal Intensive Care Unit - Medical Surgical Fetal-Neonatal Department, Meyer University Children’s’ Hospital
(2)
Neonatal Intensive Care Unit, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, Università degli Studi di Milano
(3)
Neonatal Intensive Care Unit, MBBM Foundation, San Gerardo Hospital
(4)
Department of Pediatrics, Obstetrics and Reproductive Medicine, Neonatal Intensive Care Unit, University Hospital of Siena
(5)
Department of Molecular and Developmental Medicine, University of Siena
(6)
Neonatal Intensive Care Unit, Del Ponte Hospital
(7)
Neonatal Intensive Care Unit, Children’s Hospital, University Hospital “Spedali Civili” of Brescia
(8)
Pediatric Ophthalmology, A. Meyer” University Children’s Hospital
(9)
Department of Ophthalmology, Fondazione IRCCS Cà Granda, Ospedale Maggiore Policlinico, Università degli Studi di Milano
(10)
Department of Ophthalomolgy, ASST Monza, San Gerardo Hospital
(11)
Pediatric Ophthalmology, University Hospital of Siena
(12)
Department of Surgical and Morphological Sciences, Section of Ophthalmology, University of Insubria
(13)
Department of Ophthalmology, University Hospital “Spedali Civili” of Brescia
(14)
Department of Neurosciences, Psychology, Pharmacology and Child Health, University of Florence, Newborn Screening, Biochemistry and Pharmacology Laboratory, Meyer Children’s University Hospital
(15)
Laboratory “G.A. Maccacro”, Department of Clinical Sciences and Community Health, University of Milan
(16)
Department of Biology, Unit of General Physiology, University of Pisa
(17)
Department of Pharmacy, “A. Meyer” University Children’s Hospital
(18)
Clinical Trial Office, “A. Meyer” University Children’s Hospital
(19)
Department of Pediatrics, Maastricht University Medical Center (MUMC+), School for Oncology and Developmental Biology (GROW)

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