Evidence map›Paper›PMID 25569128›Full record

Trial reportBMJ (Clinical research ed.)2015

Cerebral near infrared spectroscopy oximetry in extremely preterm infants: phase II randomised clinical trial.

Simon Hyttel-Sorensen, Adelina Pellicer, Thomas Alderliesten, Topun Austin, Frank van Bel, Manon Benders, Olivier Claris, Eugene Dempsey, Axel R Franz, Monica Fumagalli and 12 more

4 registry-linked trialsOpen access · hybridAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMJ (Clinical research ed.), 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 4 registered trials, which are not on this map. Cited by 132 papers, 10 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
132citing papers in PubMed, 10 pooled it
19.4field-weighted citation impact, top 1% 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.

NCT01590316 nacompletednot on this map

SafeBoosC - Safeguarding the Brain of Our Smallest Children - an Investigator-initiated Randomised, Blinded, Multinational, Phase II Feasibility Clinical Trial on Near-infrared Spectroscopy Monitoring Combined With Defined Treatment Guidelines Versus Standard Monitoring and Treatment as Usual in Premature Infants

TypeinterventionalSponsorGorm GreisenRan2012 to 2018Enrolled165ConditionsBrain Injuries, Infant, PrematureArmsCerebral NIRS oximetry
NCT03770741 nacompletednot on this mapstarted 2019, after this paper: background citation

Safeguarding the Brain of Our Smallest Children - an Investigator-initiated, Pragmatic, Open Label, Multinational Randomized Phase IIIclinical Trial Evaluating Treatment Based on Near-infrared Spectroscopy Monitoring Versus Treatment as Usual in Premature Infants

TypeinterventionalSponsorGorm GreisenRan2019 to 2021Enrolled1,601ConditionsInfant, Extremely Premature, Brain Injuries, Death, Brain, DeathArmsModify cardio-respiratory support to avoid cerebral hypoxia, Treatment as usual
NCT03786497 unknown statusnot on this mapstarted 2021, after this paper: background citation

Protecting Brains and Saving Futures - the PBSF Protocol: a Prospective Multicenter and Observational Study on the Use of Telemedicine for Neurocritical Care in High-risk Newborns in Brazil.

Typeobservational_patient_registrySponsorProtecting Brains Saving FuturesRan2021 to 2023Enrolled2,268ConditionsBrain Injuries, Congenital Heart Disease, Newborn Morbidity, Intraventricular Hemorrhage
NCT05065424 phase4completednot on this mapstarted 2022, after this paper: background citation

Use of Premedication for Less Invasive Surfactant Administration: A Randomized Control Trial

TypeinterventionalSponsorUniversity of Texas Southwestern Medical CenterRan2022 to 2026Enrolled58ConditionsRespiratory Distress Syndrome, NewbornArmsIV Atropine and Fentanyl Premedication Arm, IV Normal Saline Placebo Arm
3 · Its place in the literature

Who cites it

132 citing papers in PubMed, 10 syntheses or guidelines pooled it, 309 citations in OpenAlex.

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72 more citing papers are in PubMed but not listed here.

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

22 authors at 13 institutions in 10 countries.

Simon Hyttel-SorensenDepartment of Neonatology, Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9, DK-2100 Copenhagen, Denmark.
Adelina PellicerDepartment of Neonatology, La Paz University Hospital, Madrid, Spain.
Thomas AlderliestenUniversity Medical Center Utrecht, Wilhelmina Children's Hospital, Utrecht, Netherlands.
Topun AustinRosie Hospital, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK.
Frank van BelUniversity Medical Center Utrecht, Wilhelmina Children's Hospital, Utrecht, Netherlands.
Manon BendersUniversity Medical Center Utrecht, Wilhelmina Children's Hospital, Utrecht, Netherlands Centre of the Developing Brain, King's College London, London, UK.
Olivier ClarisDepartment of Neonatology, Hopital Femme Mere Enfants, Bron, France.
Eugene DempseyDepartment of Paediatrics and Child Health, University College Cork, Cork, Republic of Ireland.
Axel R FranzDepartment of Neonatology, University Children's Hospital Tübingen, Tübingen, Germany.
Monica FumagalliNICU, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.
Christian GluudCopenhagen Trial Unit, Centre for Clinical Intervention Research, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.
Berit GrevstadCentre for Clinical Intervention Research, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.
Cornelia HagmannDivision of Neonatology, University of Zurich, Zurich, Switzerland.
Petra LemmersUniversity Medical Center Utrecht, Wilhelmina Children's Hospital, Utrecht, Netherlands.
Wim van OeverenHaemoscan, Groningen, Netherlands.
Gerhard PichlerDepartment of Pediatrics, Medical University of Graz, Graz, Austria.
Anne Mette PlomgaardDepartment of Neonatology, Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9, DK-2100 Copenhagen, Denmark.
Joan RieraDepartment of Neonatology, La Paz University Hospital, Madrid, Spain Center for Biomedical Technology, Technical University of Madrid, Madrid, Spain.
Laura SanchezDepartment of Neonatology, La Paz University Hospital, Madrid, Spain.
Per WinkelCopenhagen Trial Unit, Centre for Clinical Intervention Research, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.
Martin WolfBiomedical Optics Research Laboratory, Division of Neonatology, University Hospital Zurich, Zurich, Switzerland.
Gorm GreisenDepartment of Neonatology, Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9, DK-2100 Copenhagen, Denmark.
Rigshospitalet · DKWilhelmina Children's Hospital · NLCopenhagen University Hospital · DKHospital Universitario La Paz · ESCambridge University Hospitals NHS Foundation Trust · GBFondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico · ITHôpital Femme Mère Enfant · FRMedical University of Graz · ATUniversidad Politécnica de Madrid · ESUniversity Children's Hospital Tübingen · DEUniversity College Cork · IEUniversity Medical Center Utrecht · NLUniversity of Zurich · CH

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo determine if it is possible to stabilise the cerebral oxygenation of extremely preterm infants monitored by cerebral near infrared spectroscopy (NIRS) oximetry.

designPhase II randomised, single blinded, parallel clinical trial.

settingEight tertiary neonatal intensive care units in eight European countries.

participants166 extremely preterm infants born before 28 weeks of gestation: 86 were randomised to cerebral NIRS monitoring and 80 to blinded NIRS monitoring. The only exclusion criterion was a decision not to provide life support.

interventionsMonitoring of cerebral oxygenation using NIRS in combination with a dedicated treatment guideline during the first 72 hours of life (experimental) compared with blinded NIRS oxygenation monitoring with standard care (control).

main outcome measuresThe primary outcome measure was the time spent outside the target range of 55-85% for cerebral oxygenation multiplied by the mean absolute deviation, expressed in %hours (burden of hypoxia and hyperoxia). One hour with an oxygenation of 50% gives 5%hours of hypoxia. Secondary outcomes were all cause mortality at term equivalent age and a brain injury score assessed by cerebral ultrasonography. RANDOMISATION: Allocation sequence 1:1 with block sizes 4 and 6 in random order concealed for the investigators. The allocation was stratified for gestational age (<26 weeks or ≥ 26 weeks). BLINDING: Cerebral oxygenation measurements were blinded in the control group. All outcome assessors were blinded to group allocation.

resultsThe 86 infants randomised to the NIRS group had a median burden of hypoxia and hyperoxia of 36.1%hours (interquartile range 9.2-79.5%hours) compared with 81.3 (38.5-181.3) %hours in the control group, a reduction of 58% (95% confidence interval 35% to 73%, P<0.001). In the experimental group the median burden of hypoxia was 16.6 (interquartile range 5.4-68.1) %hours, compared with 53.6 (17.4-171.3) %hours in the control group (P=0.0012). The median burden of hyperoxia was similar between the groups: 1.2 (interquartile range 0.3-9.6) %hours in the experimental group compared with 1.1 (0.1-23.4) %hours in the control group (P=0.98). We found no statistically significant differences between the two groups at term corrected age. No severe adverse reactions were associated with the device.

conclusionsCerebral oxygenation was stabilised in extremely preterm infants using a dedicated treatment guideline in combination with cerebral NIRS monitoring.Trial registration ClinicalTrial.gov NCT01590316.

Indexed as

Guideline AdherenceIntensive Care, NeonatalOximetrySpectroscopy, Near-InfraredBrainCerebrovascular CirculationClinical ProtocolsEuropeHumansHypoxiaInfant, Extremely PrematureInfant, NewbornIntensive Care Units, NeonatalMonitoring, PhysiologicPractice Guidelines as TopicTime Factors

Identifiers

PMID25569128
PMCPMC4283997
OpenAlexW2012091866

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.