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NCT03920761: ETNA

Evaluation of Technologies for Neonates in Africa

Completed Last updated 17 February 2021
What this trial tests

trial testing EarlySense Insight system in Neonatal Physiology in 575 participants. Completed in 30 December 2020.

Timeline
27 June 2019
Primary endpoint
15 December 2020
30 December 2020

Quick facts

Lead sponsorSave the Children
StatusCompleted
Study typeOBSERVATIONAL
Enrollment575
Start date27 June 2019
Primary completion15 December 2020
Estimated completion30 December 2020
Sites2 locations across Kenya

Drugs / interventions tested

Conditions studied

Sponsor

Save the Children — full company profile →

Who can join

Adults 1 Day to 28 Days, any sex, with Neonatal Physiology. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a diagnostic accuracy evaluation and clinical feasibility study of investigational devices (EarlySense and ANNE systems) in a neonatal high dependency unit (nHDU) in a private teaching hospital and a government maternity hospital in Nairobi, Kenya. Neonates who are admitted for routine observation and care will be enrolled.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Evaluation of non-invasive continuous physiological monitoring devices for neonates in Nairobi, Kenya: a research protocol.
    Ginsburg AS, Nkwopara E, Macharia W, Ochieng R, et al · · 2020 · cited 15× · PMID 32284391 · DOI 10.1136/bmjopen-2019-035184
  2. Qualitative study exploring the feasibility, usability and acceptability of neonatal continuous monitoring technologies at a public tertiary hospital in Nairobi, Kenya.
    Kinshella MW, Naanyu V, Chomba D, Waiyego M, et al · · 2022 · cited 7× · PMID 35017248 · DOI 10.1136/bmjopen-2021-053486
  3. Clinical feasibility of an advanced neonatal epidermal multiparameter continuous monitoring technology in a large public maternity hospital in Nairobi, Kenya.
    Ginsburg AS, Zandi Nia S, Chomba D, Parsimei M, et al · · 2022 · cited 6× · PMID 35810244 · DOI 10.1038/s41598-022-16051-3
  4. Clinical feasibility of a contactless multiparameter continuous monitoring technology for neonates in a large public maternity hospital in Nairobi, Kenya.
    Ginsburg AS, Zandi Nia S, Chomba D, Dunsmuir D, et al · · 2022 · cited 5× · PMID 35197529 · DOI 10.1038/s41598-022-07189-1
  5. Evaluation of a contactless neonatal physiological monitor in Nairobi, Kenya.
    Wang D, Macharia WM, Ochieng R, Chomba D, et al · · 2022 · cited 4× · PMID 34740876 · DOI 10.1136/archdischild-2021-322344

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Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03920761.

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