Evidence map›Paper›PMID 40388896›Full record

ArticleNeonatology2025

Accuracy and Safety of a Continuous Noninvasive Blood Pressure Monitor in Neonates.

R Brandon Hunter, Michele S Saruwatari, Nathan D Bliss, Sarah Kim, Rodica Turcu, Brooke A Krbec, Kamran Yusuf, Anoop Rao, Xina Quan, Lamia Soghier and 1 more

Abstract readMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Article in Neonatology, 2025. 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
–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.

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.

  1. 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

11 authors.

R Brandon HunterTexas Children's Hospital, Houston, Texas, USA.
Michele S SaruwatariChildren's National Hospital, Washington, DC, USA.
Nathan D BlissMcGovern Medical School, UT Health, Houston, Texas, USA.
Sarah KimBaylor College of Medicine, Houston, Texas, USA.
Rodica TurcuMassachusetts General Hospital, Boston, Massachusetts, USA.
Brooke A KrbecTufts Medical Center, Boston, Massachusetts, USA.
Kamran YusufAlberta Children's Hospital, Calgary, Alberta, Canada.
Anoop RaoLucile Packard Children's Hospital, Palo, Alto, California, USA.
Xina QuanPyrAmes, Inc., Cupertino, California, USA.
Lamia SoghierChildren's National Hospital, Washington, DC, USA.
Boppli Research Group

Funding

Continuous Non-Invasive Blood Pressure Monitor for NeonatesR43HD101175 · NICHD · PYRAMES, INC. · PI QUAN, XINA · 2020 to 2020
$225k
FDA HHS P50 FD006428NICHD NIH HHS R43 HD101175
6 · The paper itself

Abstract

introductionAccurate and continuous blood pressure (BP) monitoring in neonates is crucial in the intensive care unit. Invasive arterial lines (IALs), oscillometric cuffs, and current noninvasive continuous BP monitoring devices have significant limitations. The Boppli® device is a novel, continuous, noninvasive BP device that requires no calibration, designed for neonates.

methodsThis prospective, multicenter study evaluated the performance, usability, and safety of the Boppli device in neonates <5 kg. We compared mean arterial pressure (MAP), systolic blood pressure (SBP), and diastolic blood pressure (DBP) measurements from the Boppli with IAL reference values by calculating average values of mean average error (MAE) and standard deviation (SD) for each patient, then averaging those means. Safety and usability were evaluated by analysis of adverse events and survey data, respectively.

resultsThe Boppli device demonstrated good performance, meeting the FDA requirements of MAE and SD of the entire cohort: MAE (SD) 0.7 (5.3) mm Hg for MAP, -0.8 (7.7) mm Hg for SBP, and 1.4 (4.7) mm Hg for DBP. Patients with elevated MAPs, Asian ethnicity, and lower extremity IALs were the subgroups with MAE >±5 mm Hg. Various subgroups had SDs >8 mm Hg attributed to low sample sizes. The device received high usability scores from clinicians and parents. No serious adverse events were reported.

conclusionThe Boppli device is a promising alternative for continuous noninvasive BP monitoring in neonates, offering good accuracy and usability. The device, which received 510(k) clearance in September 2023, was well received by clinicians and parents, with a low-risk profile.

Indexed as

Blood PressureBlood Pressure DeterminationBlood Pressure MonitorsArterial PressureFemaleHumansInfant, NewbornIntensive Care Units, NeonatalMaleProspective StudiesReproducibility of ResultsContinuous hemodynamic monitoringIntensive careNoninvasive blood pressure monitoring

Identifiers

PMID40388896
PMCPMC12354324

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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.