Evidence map›Paper›PMID 28328980›Full record

Trial reportPloS one2017

Early biomarkers of brain injury and cerebral hypo- and hyperoxia in the SafeBoosC II trial.

Anne M Plomgaard, Thomas Alderliesten, Topun Austin, Frank van Bel, Manon Benders, Olivier Claris, Eugene Dempsey, Monica Fumagalli, Christian Gluud, Cornelia Hagmann and 8 more

Open access · goldAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in PloS one, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 27 papers.

0numbers the graph read from it
0cells of the map it votes in
27citing papers in PubMed
3.6field-weighted citation impact, top 6% 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, 61 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Trial
  4. Trial
  5. Review
  6. Review
  7. Article
  8. Observational
  9. Article
  10. Article
  11. Review
  12. Article
  13. Article
  14. Review
  15. Review
  16. Review
  17. Article
  18. Article
  19. Review
  20. 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 11 institutions in 9 countries.

Anne M PlomgaardDepartment of Neonatology, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.
Thomas AlderliestenUniversity Medical Center Utrecht, Wilhelmina Children's Hospital, Utrecht, The Netherlands.
Topun AustinRosie Hospital Cambridge University Hospitals NHS Foundation Trust, Cambridge, United Kingdom.
Frank van BelUniversity Medical Center Utrecht, Wilhelmina Children's Hospital, Utrecht, The Netherlands.
Manon BendersUniversity Medical Center Utrecht, Wilhelmina Children's Hospital, Utrecht, The Netherlands.
Olivier ClarisDepartment of Neonatology, Hospices Civils de Lyon, Claude Bernard University, Lyon, France.
Eugene DempseyINFANT Centre, University College Cork, Cork, Ireland.
Monica FumagalliNICU,Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Università degli Studi di Milano, Milan, Italy.
Christian GluudCopenhagen Trial Unit, Centre for Clinical Intervention Research, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.
Cornelia HagmannClinic of Neonatology, University of Zurich, Zurich, Switzerland.
Simon Hyttel-SorensenDepartment of Neonatology, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.
Petra LemmersUniversity Medical Center Utrecht, Wilhelmina Children's Hospital, Utrecht, The Netherlands.
Wim van OeverenHaemoscan B.V., Groningen, The Netherlands.
Adelina PellicerDepartment of Neonatology, La Paz University Hospital, Madrid, Spain.
Tue H PetersenResearch Unit on Brain Injury Neurorehabilitation Copenhagen, Department of Neurorehabilitation, TBI Unit, Rigshospitalet, Copenhagen University Hospital, Hvidovre, Denmark.
Gerhard PichlerDepartment of Pediatrics, Research Unit for Neonatal Micro- and Macrocirculation, Medical University of Graz, Graz, Austria.
Per WinkelCopenhagen Trial Unit, Centre for Clinical Intervention Research, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.
Gorm GreisenDepartment of Neonatology, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.
Copenhagen University Hospital · DKWilhelmina Children's Hospital · NLRigshospitalet · DKCambridge University Hospitals NHS Foundation Trust · GBFondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico · ITHospices Civils de Lyon · FRHospital Universitario La Paz · ESInfant · IEMedical University of Graz · ATUniversity Medical Center Utrecht · NLUniversity of Zurich · CH

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe randomized clinical trial, SafeBoosC II, examined the effect of monitoring of cerebral oxygenation by near-infrared spectroscopy combined with a guideline on treatment when cerebral oxygenation was out of the target range. Data on cerebral oxygenation was collected in both the intervention and the control group. The primary outcome was the reduction in the burden of cerebral hypo- and hyperoxia between the two groups. In this study we describe the associations between the burden of cerebral hypo- and hyperoxia, regardless of allocation to intervention or control group, and the biomarkers of brain injury from birth till term equivalent age that was collected as secondary and explorative outcomes in the SafeBoosC II trial.

methodsCerebral oxygenation was continuously monitored during the first 72h of life in 166 extremely preterm infants. Cranial ultrasound was performed at day 1,4,7,14, and 35 and at term. Electroencephalogram (EEG) was recorded at 64h. Blood-samples taken at 6 and 64 hours were analysed for the brain injury biomarkers; S100beta, brain-fatty-acid-binding-protein, and neuroketal. All analyses were conducted post hoc.

resultsSignificantly more infants with a cerebral burden of hypoxia within the 4th quartile versus infants within quartile 1-3 were diagnosed with severe intracranial haemorrhage (11/39 versus 11/117, p = 0.003), had low burst rate on EEG (12/28 versus 21/103, p = 0.015), or died (14/41 versus 18/123, p = 0.006), whereas none of these events were significantly associated with cerebral hyperoxia. The blood biomarkers were not significantly associated with the burden of cerebral hypo- or hyperoxia.

conclusionsThe explorative analysis showed that early burden of cerebral hypoxia, but not hyperoxia was significantly associated with low brain electrical activity and severe intracranial haemorrhage while none of the three blood biomarkers were associated with the burden of either cerebral hypo- or hyperoxia.

Indexed as

BiomarkersBrain InjuriesElectroencephalographyFemaleGestational AgeHumansHyperoxiaHypoxia, BrainInfant, Extremely PrematureInfant, NewbornMaleMonitoring, PhysiologicOximetryOxygenSpectroscopy, Near-InfraredBiomarkersOxygen

Identifiers

PMID28328980
PMCPMC5362210
OpenAlexW2598984008

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.