Evidence map›Paper›PMID 27814346›Full record

Trial reportPediatric research2017

Propranolol 0.1% eye micro-drops in newborns with retinopathy of prematurity: a pilot clinical trial.

Luca Filippi, Giacomo Cavallaro, Paola Bagnoli, Massimo Dal Monte, Patrizio Fiorini, Elettra Berti, Letizia Padrini, Gianpaolo Donzelli, Gabriella Araimo, Gloria Cristofori and 14 more

Open access · bronzeAbstract readClinical Trial, Phase IIMulticenter Study
PubMed Publisher
In one paragraph

Trial report in Pediatric research, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 27 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
27citing papers in PubMed, 4 pooled it
3.1field-weighted citation impact, top 9% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

27 citing papers in PubMed, 4 syntheses or guidelines pooled it, 38 citations in OpenAlex.

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  9. Optimizing instilled drug delivery: a scoping review of microdrops in ophthalmology.Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie · 2025
    Article
  10. [Advances in pharmacological research for retinopathy of prematurity].Zhejiang da xue xue bao. Yi xue ban = Journal of Zhejiang University. Medical sciences · 2025
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

24 authors at 7 institutions in 1 country.

Luca FilippiNeonatal Intensive Care Unit, Medical Surgical Fetal-Neonatal Department, "A. Meyer" University Children's Hospital, Florence, Italy.
Giacomo CavallaroNeonatal Intensive Care Unit, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, University of Milan, Milan, Italy.
Paola BagnoliDepartment of Biology, Unit of General Physiology, University of Pisa, Pisa, Italy.
Massimo Dal MonteDepartment of Biology, Unit of General Physiology, University of Pisa, Pisa, Italy.
Patrizio FioriniNeonatal Intensive Care Unit, Medical Surgical Fetal-Neonatal Department, "A. Meyer" University Children's Hospital, Florence, Italy.
Elettra BertiNeonatal Intensive Care Unit, Medical Surgical Fetal-Neonatal Department, "A. Meyer" University Children's Hospital, Florence, Italy.
Letizia PadriniNeonatal Intensive Care Unit, Medical Surgical Fetal-Neonatal Department, "A. Meyer" University Children's Hospital, Florence, Italy.
Gianpaolo DonzelliNeonatal Intensive Care Unit, Medical Surgical Fetal-Neonatal Department, "A. Meyer" University Children's Hospital, Florence, Italy.
Gabriella AraimoNeonatal Intensive Care Unit, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, University of Milan, Milan, Italy.
Gloria CristoforiNeonatal Intensive Care Unit, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, University of Milan, Milan, Italy.
Monica FumagalliNeonatal Intensive Care Unit, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, University of Milan, Milan, Italy.
Giancarlo la MarcaDepartment of Neurosciences, Psychology, Pharmacology and Child Health, University of Florence, Newborn Screening, Biochemistry and Pharmacology Laboratory, Meyer Children's University Hospital, Florence, Italy.
Maria Luisa Della BonaDepartment of Neurosciences, Psychology, Pharmacology and Child Health, University of Florence, Newborn Screening, Biochemistry and Pharmacology Laboratory, Meyer Children's University Hospital, Florence, Italy.
Roberta PasqualettiPediatric Ophthalmology, A. Meyer" University Children's Hospital, Florence, Italy.
Pina FortunatoPediatric Ophthalmology, A. Meyer" University Children's Hospital, Florence, Italy.
Silvia OsnaghiDepartment of Ophthalmology, Fondazione IRCCS Cà Granda, Ospedale Maggiore Polclinico, Milan, Italy.
Barbara TomasiniDepartment of Pediatrics, Obstetrics and Reproductive Medicine, Neonatal Intensive Care Unit, University Hospital of Siena, Policlinico Santa Maria alle Scotte, Siena, Italy.
Maurizio VanniDepartment of Pediatrics, Obstetrics and Reproductive Medicine, Neonatal Intensive Care Unit, University Hospital of Siena, Policlinico Santa Maria alle Scotte, Siena, Italy.
Anna Maria CalvaniDepartment of Pharmacy, "A. Meyer" University Children's Hospital, Florence, Italy.
Silvano MilaniLaboratory "G.A. Maccacro", Department of Clinical Sciences and Community Health, University of Milan, Milan, Italy.
Ivan CortinovisLaboratory "G.A. Maccacro", Department of Clinical Sciences and Community Health, University of Milan, Milan, Italy.
Alessandra PugiClinical Trial Office, "A. Meyer" University Children's Hospital, Florence, Italy.
Massimo AgostiNeonatal Intensive Care Unit, Del Ponte Hospital, Varese, Italy.
Fabio MoscaNeonatal Intensive Care Unit, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, University of Milan, Milan, Italy.
Meyer Children's Hospital · ITUniversity of Milan · ITFondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico · ITOspedale Santa Maria alle Scotte · ITUniversity of Pisa · ITOspedale Filippo Del Ponte Varese · ITUniversity of Florence · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundOral 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.

methodsA 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.

resultsTwenty-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.

conclusionPropranolol 0.1% eye micro-drops are well tolerated, but not sufficiently effective. Further studies are required to identify the optimal dose and administration schedule.

Indexed as

Administration, OphthalmicAdministration, OralAdministration, TopicalDisease ProgressionFemaleHemodynamicsHumansInfant, NewbornMaleNeovascularization, PhysiologicPatient SafetyPilot ProjectsPropranololRespirationRetinopathy of PrematurityPropranolol

Identifiers

PMID27814346
OpenAlexW2547537143

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.