Evidence map›Paper›PMID 28723887›Full record

ArticlePediatric research2017

In vitro and in vivo characterization of poractant alfa supplemented with budesonide for safe and effective intratracheal administration.

Francesca Ricci, Chiara Catozzi, Francesca Ravanetti, Xabier Murgia, Francesco D'Aló, Natalia Macchidani, Elisa Sgarbi, Valentina Di Lallo, Federica Saccani, Marisa Pertile and 8 more

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Article in Pediatric research, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed, 1 pooled it
2.7field-weighted citation impact, top 10% 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

20 citing papers in PubMed, 1 synthesis or guideline pooled it, 35 citations in OpenAlex.

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  19. Surfactant plus budesonide decreases lung and systemic inflammation in mechanically ventilated preterm sheep.American journal of physiology. Lung cellular and molecular physiology · 2019
    Article
  20. Effects of budesonide and surfactant in preterm fetal sheep.American journal of physiology. Lung cellular and molecular physiology · 2018
    Article
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

18 authors at 3 institutions in 2 countries.

Francesca RicciR&D Department, Chiesi Farmaceutici, Parma, Italy.
Chiara CatozziR&D Department, Chiesi Farmaceutici, Parma, Italy.
Francesca RavanettiDepartment of Veterinary Science, University of Parma, Parma, Italy.
Xabier MurgiaDepartment of Drug Delivery, Helmholtz Institute for Pharmaceutical Research Saarland, Saarbrücken, Germany.
Francesco D'AlóR&D Department, Chiesi Farmaceutici, Parma, Italy.
Natalia MacchidaniR&D Department, Chiesi Farmaceutici, Parma, Italy.
Elisa SgarbiR&D Department, Chiesi Farmaceutici, Parma, Italy.
Valentina Di LalloR&D Department, Chiesi Farmaceutici, Parma, Italy.
Federica SaccaniR&D Department, Chiesi Farmaceutici, Parma, Italy.
Marisa PertileR&D Department, Chiesi Farmaceutici, Parma, Italy.
Antonio CacchioliDepartment of Veterinary Science, University of Parma, Parma, Italy.
Silvia CatinellaR&D Department, Chiesi Farmaceutici, Parma, Italy.
Gino VillettiR&D Department, Chiesi Farmaceutici, Parma, Italy.
Maurizio CivelliR&D Department, Chiesi Farmaceutici, Parma, Italy.
Francesco AmadeiR&D Department, Chiesi Farmaceutici, Parma, Italy.
Fabio Franco StellariR&D Department, Chiesi Farmaceutici, Parma, Italy.
Barbara PioselliR&D Department, Chiesi Farmaceutici, Parma, Italy.
Fabrizio SalomoneR&D Department, Chiesi Farmaceutici, Parma, Italy.
Chiesi (Italy) · ITUniversity of Parma · ITHelmholtz Institute for Pharmaceutical Research Saarland · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BackgroundThe intratracheal (IT) administration of budesonide using surfactant as a vehicle has been shown to reduce the incidence of bronchopulmonary dysplasia (BPD) in preterm infants. The objective of this study was to characterize the in vitro characteristics and in vivo safety and efficacy of the extemporaneous combination of budesonide and poractant alfa.MethodsThe stability, minimum surface tension, and viscosity of the preparation were evaluated by means of high-performance liquid chromatography (HPLC), Wilhelmy balance, and Rheometer, respectively. The safety and efficacy of the IT administration of the mixture were tested in two respiratory distress syndrome (RDS) animal models: twenty-seventh day gestational age premature rabbits and surfactant-depleted adult rabbits.ResultsA pre-formulation trial identified a suitable procedure to ensure the homogeneity and stability of the formulation. Wilhelmy Balance tests clarified that budesonide supplementation has no detrimental effect on poractant alfa surface tension activity. The addition of budesonide to poractant alfa did not affect the physiological response to surfactant treatment in both RDS animal models, and was associated to a significant reduction of lung inflammation in surfactant-depleted rabbits.ConclusionOur in vitro and in vivo analysis suggests that the IT administration of a characterized extemporaneous combination of poractant alfa and budesonide is a safe and efficacious procedure in the context of RDS.

Indexed as

AnimalsBiological ProductsBronchoalveolar Lavage FluidBronchodilator AgentsBronchopulmonary DysplasiaBudesonideDisease Models, AnimalDrug Administration RoutesFemaleIn Vitro TechniquesPhospholipidsPregnancyPulmonary SurfactantsRabbitsRespiratory Distress Syndrome, NewbornSurface TensionBiological ProductsBronchodilator AgentsBudesonidePhospholipidsporactant alfaPulmonary Surfactants

Identifiers

PMID28723887
OpenAlexW2738808006

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.