Evidence map›Paper›PMID 34740876›Full record

Observational studyArchives of disease in childhood2022

Evaluation of a contactless neonatal physiological monitor in Nairobi, Kenya.

Dee Wang, William M Macharia, Roseline Ochieng, Dorothy Chomba, Yifat S Hadida, Roman Karasik, Dustin Dunsmuir, Jesse Coleman, Guohai Zhou, Amy Sarah Ginsburg and 1 more

Registry-linked trialOpen access · hybridAbstract readObservational Study
In one paragraph

Observational study in Archives of disease in childhood, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03920761 (Evaluation of Technologies for Neonates in Africa), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
0.2field-weighted citation impact, top 54% 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.

NCT03920761 completednot on this map

Evaluation of Technologies for Neonates in Africa

TypeobservationalSponsorSave the ChildrenRan2019 to 2020Enrolled575ConditionsNeonatal PhysiologyArmsEarlySense Insight system, Advanced Neonatal Epidermal System
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 4 citations in OpenAlex.

  1. Article
  2. Article
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  4. 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 at 5 institutions in 4 countries.

Dee WangDepartment of Anesthesiology, Pharmacology and Therapeutics, The University of British Columbia, Vancouver, British Columbia, Canada deewang62108@gmail.com.ORCID 0000-0002-5125-6538
William M MachariaDepartment of Pediatrics, Aga Khan University, Nairobi, Kenya.
Roseline OchiengDepartment of Pediatrics, Aga Khan University, Nairobi, Kenya.
Dorothy ChombaDepartment of Pediatrics, Aga Khan University, Nairobi, Kenya.
Yifat S HadidaEarlySense, Ramat Gan, Tel Aviv, Israel.
Roman KarasikEarlySense, Ramat Gan, Tel Aviv, Israel.
Dustin DunsmuirDepartment of Anesthesiology, Pharmacology and Therapeutics, The University of British Columbia, Vancouver, British Columbia, Canada.
Jesse ColemanCentre for International Child Health, Vancouver, British Columbia, Canada.
Guohai ZhouCenter for Clinical Investigation, Brigham and Women's Hospital, Boston, Massachusetts, USA.
Amy Sarah GinsburgClinical Trials Center, University of Washington, Seattle, Washington, USA.ORCID 0000-0002-2291-2276
J Mark AnserminoDepartment of Anesthesiology, Pharmacology and Therapeutics, The University of British Columbia, Vancouver, British Columbia, Canada.
Aga Khan University Nairobi · KEUniversity of British Columbia · CAEarlySense (Israel) · ILBrigham and Women's Hospital · USUniversity of Washington · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundGlobally, 2.5 million neonates died in 2018, accounting for 46% of under-5 deaths. Multiparameter continuous physiological monitoring (MCPM) of neonates allows for early detection and treatment of life-threatening health problems. However, neonatal monitoring technology is largely unavailable in low-resource settings.

methodsIn four evaluation rounds, we prospectively compared the accuracy of the EarlySense under-mattress device to the Masimo Rad-97 pulse CO-oximeter with capnography reference device for heart rate (HR) and respiratory rate (RR) measurements in neonates in Kenya. EarlySense algorithm optimisations were made between evaluation rounds. In each evaluation round, we compared 200 randomly selected epochs of data using Bland-Altman plots and generated Clarke error grids with zones of 20% to aid in clinical interpretation.

resultsBetween 9 July 2019 and 8 January 2020, we collected 280 hours of MCPM data from 76 enrolled neonates. At the final evaluation round, the EarlySense MCPM device demonstrated a bias of -0.8 beats/minute for HR and 1.6 breaths/minute for RR, and normalised spread between the 95% upper and lower limits of agreement of 6.2% for HR and 27.3% for RR. Agreement between the two MCPM devices met the a priori-defined threshold of 30%. The Clarke error grids showed that all observations for HR and 197/200 for RR were within a 20% difference.

conclusionOur research indicates that there is acceptable agreement between the EarlySense and Masimo MCPM devices in the context of large within-subject variability; however, further studies establishing cost-effectiveness and clinical effectiveness are needed before large-scale implementation of the EarlySense MCPM device in neonates. TRIAL REGISTRATION NUMBER: NCT03920761.

Indexed as

OximetryRespiratory RateHeart RateHumansInfant, NewbornKenyaMonitoring, Physiologicintensive care unitsneonatalneonatologytechnology

Identifiers

PMID34740876
PMCPMC9125375
OpenAlexW3210527010

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.