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NCT03849781

The NeoBeat Efficacy Study for Newborns

Status unknown NA Last updated 15 May 2019
What this trial tests

NA trial testing NeoBeat with a visible display in Newborn Resuscitation in 500 participants. Status unknown.

Timeline
8 March 2019
Primary endpoint
1 July 2022
1 July 2022

Quick facts

Lead sponsorHelse Stavanger HF
PhaseNA
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposesupportive care
Enrollment500
Start date8 March 2019
Primary completion1 July 2022
Estimated completion1 July 2022
Sites1 location across Norway

Drugs / interventions tested

Conditions studied

Sponsor

Helse Stavanger HF — full company profile →

Who can join

Under 60 Minutes, any sex, with Newborn Resuscitation or Heart Rate Monitoring. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

In a multicenter randomized controlled trial the investigators will evaluate the efficacy of the novel heart rate meter NeoBeat on ventilation performance and short-term outcomes compared to standard care in newborns in need of positive pressure ventilation to initiate spontaneous breathing after birth.

Publications & conference data

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

  1. Comparison of Heart Rate Feedback from Dry-Electrode ECG, 3-Lead ECG, and Pulse Oximetry during Newborn Resuscitation.
    Rettedal S, Eilevstjønn J, Kibsgaard A, Kvaløy JT, et al · · 2021 · cited 19× · PMID 34943288 · DOI 10.3390/children8121092
  2. Prevalence of bradycardia in 4876 newborns in the first minute after birth and association with positive pressure ventilation: a population-based cross-sectional study.
    Rettedal S, Kibsgaard A, Kvaløy JT, Eilevstjønn J, et al · · 2024 · cited 7× · PMID 37940377 · DOI 10.1136/archdischild-2023-325878
  3. Impact of immediate and continuous heart rate feedback by dry electrode ECG on time to initiation of ventilation after birth: protocol for a randomised controlled trial.
    Rettedal S, Kibsgaard A, Eilevstjønn J, Kvaløy JT, et al · · 2022 · cited 7× · PMID 36691167 · DOI 10.1136/bmjopen-2022-061839
  4. Impact of Heart Rate Monitoring Using Dry-Electrode ECG Immediately After Birth on Time to Start Ventilation: A Randomized Trial.
    Rettedal S, Kibsgaard A, Buskov F, Eilevstjønn J, et al · · 2025 · PMID 40868533 · DOI 10.3390/children12081082

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Other Helse Stavanger HF trials

Trials by the same sponsor.

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Data sources for this page

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/NCT03849781.

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