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NCT03849781
The NeoBeat Efficacy Study for Newborns
NA trial testing NeoBeat with a visible display in Newborn Resuscitation in 500 participants. Status unknown.
1 July 2022
Quick facts
| Lead sponsor | Helse Stavanger HF |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | supportive care |
| Enrollment | 500 |
| Start date | 8 March 2019 |
| Primary completion | 1 July 2022 |
| Estimated completion | 1 July 2022 |
| Sites | 1 location across Norway |
Drugs / interventions tested
- NeoBeat with a visible display
Conditions studied
- Newborn Resuscitation — all drugs for Newborn Resuscitation →
- Heart Rate Monitoring — all drugs for Heart Rate Monitoring →
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):
-
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 -
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 -
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 -
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
Verify or expand the search:
- PubMed search for NCT03849781
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03849781 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Helse Stavanger HF
- Last refreshed: 15 May 2019
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.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing