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The NeoBeat Efficacy Study for Newborns

NCT03849781 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 500

Last updated 2019-05-15

No results posted yet for this study

Summary

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.

Conditions

  • Newborn Resuscitation
  • Heart Rate Monitoring

Interventions

DEVICE

NeoBeat with a visible display

NeoBeat (Laerdal Medical) is a CE approved novel heart rate meter, able to detect heart rate in newborns within seconds of birth. The NeoBeat uses ECG dry-electrodes in a snug-fit abdomen-shaped buckle for rapid application around the newborn's abdomen or thorax. It allows healthcare providers to reliably assess heart rate of the newborn immediately after birth and continuously during resuscitation.

Sponsors & Collaborators

  • Sykehuset Østfold

    collaborator UNKNOWN

  • Laerdal Medical

    collaborator INDUSTRY

  • Helse Stavanger HF

    lead OTHER_GOV

Principal Investigators

  • Svein Skeie, MD PhD · Stavanger University Hosptial

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
60 Minutes
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-03-08
Primary Completion
2022-07-01
Completion
2022-07-01

Countries

  • Norway

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03849781 on ClinicalTrials.gov