Evidence map›Paper›PMID 36053638›Full record

ArticleBMJ paediatrics open2022

Multicentre paired non-inferiority study of the cardiorespiratory monitoring performance of the wireless and non-adhesive Bambi® belt measuring diaphragm activity in neonates: study protocol.

Anouk W J Scholten, Zhuozhao Zhan, Hendrik J Niemarkt, Marieke Vervoorn, Ruud W van Leuteren, Frans H de Jongh, Anton H van Kaam, Edwin R van den Heuvel, G Jeroen Hutten

Open access · diamondAbstract read
In one paragraph

Article in BMJ paediatrics open, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.3field-weighted citation impact, top 50% 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

1 citing paper in PubMed, 4 citations in OpenAlex.

  1. 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

9 authors at 3 institutions in 1 country.

Anouk W J Scholten *Amsterdam UMC location University of Amsterdam, Department of Neonatology, Meibergdreef 9, Amsterdam, The Netherlands a.w.j.scholten@amsterdamumc.nl.ORCID 0000-0002-6175-1436
Zhuozhao Zhan *Eindhoven University of Technology, Department of Mathematics and Computer Science, Eindhoven, The Netherlands.ORCID 0000-0001-8364-0983
Hendrik J NiemarktMáxima Medical Center, Department of Neonatology, Veldhoven, The Netherlands.ORCID 0000-0002-0844-7208
Marieke VervoornMáxima Medical Center, Department of Neonatology, Veldhoven, The Netherlands.
Ruud W van LeuterenAmsterdam UMC location University of Amsterdam, Department of Neonatology, Meibergdreef 9, Amsterdam, The Netherlands.ORCID 0000-0001-8468-2544
Frans H de JonghAmsterdam UMC location University of Amsterdam, Department of Neonatology, Meibergdreef 9, Amsterdam, The Netherlands.ORCID 0000-0002-6052-7504
Anton H van KaamAmsterdam UMC location University of Amsterdam, Department of Neonatology, Meibergdreef 9, Amsterdam, The Netherlands.ORCID 0000-0003-4030-7085
Edwin R van den HeuvelEindhoven University of Technology, Department of Mathematics and Computer Science, Eindhoven, The Netherlands.ORCID 0000-0001-9157-7224
G Jeroen HuttenAmsterdam UMC location University of Amsterdam, Department of Neonatology, Meibergdreef 9, Amsterdam, The Netherlands.ORCID 0000-0003-4368-6519
Amsterdam University Medical Centers · NLEindhoven University of Technology · NLRadboud University Nijmegen · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionCardiorespiratory monitoring is used in the neonatal intensive care unit (NICU) to assess the clinical status of newborn infants and detect critical deteriorations in cardiorespiratory function. Currently, heart rate (HR) is monitored by electrocardiography (ECG) and respiration by chest impedance (CI). Disadvantages of current monitoring techniques are usage of wired adhesive electrodes which may damage the skin and hinder care. The Bambi® belt is a wireless and non-adhesive alternative that enables cardiorespiratory monitoring by measuring electrical activity of the diaphragm via transcutaneous electromyography. A previous study showed feasibility of the Bambi® belt and this study compares the belt performance to ECG and CI. METHODS AND ANALYSIS: This multicentre non-inferiority paired study will be performed in the NICU of the Máxima Medical Center (MMC) in Veldhoven and the Emma Children's Hospital, Amsterdam University Medical Centre (AmsterdamUMC) in Amsterdam, The Netherlands. 39 infants in different postmenstrual age groups (minimally 10 infants<30 weeks, between 30-32 weeks and >32 weeks) will be recruited. These infants will be monitored with the Bambi® belt in addition to standard ECG and CI for 24 hours. The primary outcome is the HR, studied with three criteria: (1) the limits of agreement of the HR measurements in terms of the second-to-second difference in the HR between the belt and standard ECG, (2) the detection of cardiac events consisting of bradycardia and tachycardia and (3) the quality of HR-monitoring. The secondary outcome is the respiratory rate (RR), studied with the criteria (1) agreement in RR-trend monitoring, (2) apnoea and tachypnoea detection and (3) reliable registrations. ETHICS AND DISSEMINATION: This protocol was approved by the Medical Ethical Committee of the MMC and the Central Committee for Human Research. The MMC started patient recruitment in July and the AmsterdamUMC in August 2021. The results will be presented at conferences and published in peer-reviewed journals. TRIAL REGISTRATION NUMBER: NL9480.

Indexed as

AdhesivesDiaphragmChildElectrocardiographyHumansInfantInfant, NewbornMembrane ProteinsMonitoring, PhysiologicMulticenter Studies as TopicRespiratory RateAdhesivesBAMBI protein, humanMembrane ProteinsNeonatologyTechnology

Identifiers

PMID36053638
PMCPMC9185582
OpenAlexW4281691943

What OpenQuestion holds

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LicenceCC BY-NC
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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.