Evidence map›Paper›PMID 39019542›Full record

Trial reportBMJ paediatrics open2024

Performance and safety of the PRICO closed-loop oxygen saturation targeting system in neonates: pragmatic multicentre cross-over study (TarOx Study).

Maria Wilinska, Thomas Bachman, Tomasz Szczapa, Katarzyna Wroblewska-Seniuk, Karolina Chojnacka, Beata Loniewska, Karolina Olszanska, Beata Rzepecka Weglarz, Katarzyna Janusz, Pawel Piwowarczyk and 4 more

Registry-linked trialAbstract readMulticenter StudyRandomized Controlled TrialPragmatic Clinical Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMJ paediatrics open, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04957472 (Multicenter Study of the Safety and Performance of Fabian-PRICO for Saturation Targeting Routine Use in the NICU), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
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.

NCT04957472 completednot on this map

Multicenter Study of the Safety and Performance of Fabian-PRICO for Saturation Targeting Routine Use in the NICU

TypeobservationalSponsorVyaire MedicalRan2022 to 2022Enrolled47ConditionsRespiratory Insufficiency in ChildrenArmsfabian HFO, fabian +nCPAP evolution and fabian Therapy evolution with PRICO function, Manual Control
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. 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

14 authors.

Maria WilinskaDepartment of Obstetrics and Perinatology, National Medical Institute, Warsaw, Poland wilinska.maria@gmail.com.
Thomas BachmanFaculty Biomedical Engineering, Czech Technical University in Prague, Kladno, Czech Republic.ORCID http://orcid.org/0000-0002-3968-9402
Tomasz SzczapaNeonatal Biophysical Monitoring and Cardiopulmonary Therapies Research Unit, Poznan University of Medical Sciences, Poznan, Poland.ORCID http://orcid.org/0000-0002-5214-2719
Katarzyna Wroblewska-SeniukNeonatal Biophysical Monitoring and Cardiopulmonary Therapies Research Unit, Poznan University of Medical Sciences, Poznan, Poland.
Karolina ChojnackaNeonatal Biophysical Monitoring and Cardiopulmonary Therapies Research Unit, Poznan University of Medical Sciences, Poznan, Poland.
Beata LoniewskaDepartment of Neonatology, Pomeranian Medical University in Szczecin, Szczecin, Poland.
Karolina OlszanskaDepartment of Neonatology, Pomeranian Medical University in Szczecin, Szczecin, Poland.
Beata Rzepecka WeglarzDepartment of Neonatology, Ujastek Medical Cetner, Krakow, Poland.
Katarzyna JanuszDepartment of Neontology, Ujastek Medical Center, Krakow, Poland.
Pawel PiwowarczykDepartment of Neonatology, Centre for Postgraduate Medical Education, Warsaw, Poland.
Wes OnlandDepartent of Neonatology Emma Children's Hospital UMC, University of Amsterdam, Amsterdam, The Netherlands.ORCID http://orcid.org/0000-0002-9623-0606
G Jeroen HuttenDepartent of Neonatology Emma Children's Hospital UMC, University of Amsterdam, Amsterdam, The Netherlands.
Ruud W van LeuterenDepartent of Neonatology Emma Children's Hospital UMC, University of Amsterdam, Amsterdam, The Netherlands.
Anton H van KaamDepartent of Neonatology Emma Children's Hospital UMC, University of Amsterdam, Amsterdam, The Netherlands.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveThis study aims to evaluate the performance of the fabian-Predictive-Intelligent-Control-of-Oxygenation (PRICO) system for automated control of the fraction of inspired oxygen (FiO

designMulticentre randomised cross-over study.

settingFive neonatal intensive care units experienced with automated control of FiO PATIENTS: 39 infants: median gestational age of 27 weeks (IQR: 26-30), postnatal age 7 days (IQR: 2-17), weight 1120 g (IQR: 915-1588), FiO

interventionRandomised sequential 24-hour periods of automated and manual FiO

main outcome measuresProportion (%) of time in normoxaemia (90%-95% with FiO

resultsDuring automated control, subjects spent more time in normoxaemia (74%±22% vs 51%±22%, p<0.001) with less time above and below (<90% (9%±8% vs 12%±11%, p<0.001) and >95% with FiO

conclusionsThis study demonstrates the ability of the PRICO automated oxygen control algorithm to improve the maintenance of SpO

Indexed as

Cross-Over StudiesIntensive Care Units, NeonatalOxygen SaturationFemaleHumansHyperoxiaHypoxiaInfant, NewbornInfant, PrematureMaleOximetryOxygenOxygen Inhalation TherapyRespiration, ArtificialOxygenneonatologytechnology

Identifiers

PMID39019542
PMCPMC11253729

What OpenQuestion holds

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Registered trials

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.