Evidence map›Paper›PMID 35073354›Full record

Trial reportPloS one2022

Early cerebral hypoxia in extremely preterm infants and neurodevelopmental impairment at 2 year of age: A post hoc analysis of the SafeBoosC II trial.

Anne Mette Plomgaard, Christoph E Schwarz, Olivier Claris, Eugene M Dempsey, Monica Fumagalli, Simon Hyttel-Sorensen, Petra Lemmers, Adelina Pellicer, Gerhard Pichler, Gorm Greisen

Open access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in PloS one, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed
7.2field-weighted citation impact, top 3% 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

10 citing papers in PubMed, 21 citations in OpenAlex.

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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

10 authors at 7 institutions in 8 countries.

Anne Mette PlomgaardDepartment of Neonatology, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.ORCID 0000-0002-1009-6013
Christoph E SchwarzDepartment of Neonatology, University Children's Hospital, Tuebingen, Germany.
Olivier ClarisDepartment of Neonatology, Hospices Civils de Lyon, Claude Bernard University, Lyon, France.
Eugene M DempseyINFANT Centre, University College Cork, Cork, Ireland.
Monica FumagalliNICU, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.
Simon Hyttel-SorensenDepartment of Neonatology, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.
Petra LemmersWilhelmina Children's Hospital, University Medical Center Utrecht, Utrecht, The Netherlands.
Adelina PellicerDepartment of Neonatology, La Paz University Hospital, Madrid, Spain.
Gerhard PichlerDepartment of Pediatrics, Medical University of Graz, Graz, Austria.
Gorm GreisenDepartment of Neonatology, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.
Copenhagen University Hospital · DKUniversity College Cork · IEHospital Universitario La Paz · ESMedical University of Graz · ATUniversité Claude Bernard Lyon 1 · FRUniversity Medical Center Utrecht · NLUniversity of Milan · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe SafeBoosC II, randomised clinical trial, showed that the burden of cerebral hypoxia was reduced with the combination of near infrared spectroscopy and a treatment guideline in extremely preterm infants during the first 72 hours after birth. We have previously reported that a high burden of cerebral hypoxia was associated with cerebral haemorrhage and EEG suppression towards the end of the 72-hour intervention period, regardless of allocation. In this study we describe the associations between the burden of cerebral hypoxia and the 2-year outcome.

methodsCerebral oxygenation was continuously monitored from 3 to 72 hours after birth in 166 extremely preterm infants. At 2 years of age 114 of 133 surviving children participated in the follow-up program: medical examination, Bayley II or III test and the parental Ages and Stages Questionnaire. The infants were classified according to the burden of hypoxia: within the first three quartiles (n = 86, low burden) or within in the 4th quartile (n = 28, high burden). All analyses were conducted post hoc.

resultsThere were no statistically significant differences between the quantitative assessments of neurodevelopment in the groups of infants with the low burden of cerebral hypoxia versus the group of infants with the high burden of cerebral hypoxia. The infants in the high hypoxia burden group had a higher-though again not statistically significant-rate of cerebral palsy (OR 2.14 (0.33-13.78)) and severe developmental impairment (OR 4.74 (0.74-30.49).

conclusionsThe burden of cerebral hypoxia was not significantly associated with impaired 2-year neurodevelopmental outcome in this post-hoc analysis of a feasibility trial.

Indexed as

Child, PreschoolFemaleHumansHypoxia, BrainInfantInfant, Extremely PrematureInfant, NewbornMaleNeurodevelopmental DisordersSpectroscopy, Near-InfraredTreatment Outcome

Identifiers

PMID35073354
PMCPMC8786171
OpenAlexW4207070926

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Registered trials

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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.