Evidence map›Paper›PMID 39533330›Full record

ArticleTrials2024

Statistical analysis plan for the FiO

Jochem König, Anette Stauch, Corinna Engel, Michael S Urschitz, Axel R Franz, FiO2-C study group

Registry-linked trialAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03168516 (Effects of Closed-loop Automatic Control of the Inspiratory Fraction of Oxygen), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing 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.

NCT03168516 phase3active not recruitingnot on this map

Effects of Closed-loop Automatic Control of the Inspiratory Fraction of Oxygen (FiO2-C) on Outcome of Extremely Preterm Infants - a Randomized Controlled Parallel Group Multicenter Trial for Safety and Efficacy

TypeinterventionalSponsorUniversity Hospital TuebingenRan2018 to 2026Enrolled1,065ConditionsInfant,PrematureArmsclosed-loop automatic control of the inspiratory fraction of oxygen (FiO2-C)
3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Review
  2. [Application of intelligent oxygen management system in neonatal intensive care units: a scoping review].Zhongguo dang dai er ke za zhi = Chinese journal of contemporary pediatrics · 2025
    Article
  3. Review
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

6 authors.

Jochem König *Division of Paediatric Epidemiology, Institute of Medical Biostatistics, Epidemiology, and Informatics, University Medical Centre of the Johannes Gutenberg University Mainz, Mainz, Germany.
Anette Stauch *Centre for Pediatric Clinical Studies (CPCS), University Children's Hospital Tübingen, Calwerstr. 7, Tübingen, 72076, Germany.
Corinna EngelCentre for Pediatric Clinical Studies (CPCS), University Children's Hospital Tübingen, Calwerstr. 7, Tübingen, 72076, Germany.
Michael S Urschitz *Division of Paediatric Epidemiology, Institute of Medical Biostatistics, Epidemiology, and Informatics, University Medical Centre of the Johannes Gutenberg University Mainz, Mainz, Germany.
Axel R Franz *Centre for Pediatric Clinical Studies (CPCS), University Children's Hospital Tübingen, Calwerstr. 7, Tübingen, 72076, Germany. Axel.Franz@med.uni-tuebingen.de.
FiO2-C study group

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundExtremely low gestational age neonates (ELGANs, i.e. those born before 28 weeks postmenstrual age (PMA)) often require supplemental oxygen and frequently experience intermittent hypo- and hyperoxemic episodes. Exposure to episodes with inadequate oxygen concentrations has been shown to be associated with an increased risk of retinopathy of prematurity (ROP), bronchopulmonary dysplasia (BPD), necrotizing enterocolitis (NEC), neurodevelopmental impairment (NDI) and death. Closed-loop automatic control of the inspiratory fraction of oxygen (FiO

methodsAn outcome-assessor-blinded, multicentre, randomized-controlled, parallel-group trial for superiority was designed to study the effects of FiO

resultsPrimary outcomes will be compared between the two intervention groups using a Cochran-Mantel-Haenszel test. The factors considered for randomization (centre, sex and gestational age at birth (< 26 weeks and ≥ 26 weeks)) will be used to define strata. Results will be presented as adjusted odds ratios with two-sided 95% and 97.5% confidence intervals and two-sided p values.

conclusionsThe statistical analyses for the FiO

trial registrationClinicalTrials.gov NCT03168516. Registered on May 30, 2017.

Indexed as

Infant, Extremely PrematureMulticenter Studies as TopicOxygen Inhalation TherapyBronchopulmonary DysplasiaData Interpretation, StatisticalEquivalence Trials as TopicGestational AgeHumansInfant, NewbornOxygenRandomized Controlled Trials as TopicRetinopathy of PrematurityTime FactorsTreatment OutcomeOxygenClosed-loop automatic control of the inspiratory fraction of oxygen (FiO2-C)InfantIntermittent hypoxemia and hyperoxemiaOxygenPremature

Identifiers

PMID39533330
PMCPMC11559155

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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.