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HeartLight Pulse Study: Evaluation of Heart Rate Using an Electronic Stethoscope and Pre Placed ECG in the Delivery Room

NCT02747069 · Status: SUSPENDED · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2018-05-17

No results posted yet for this study

Summary

This study will evaluate the accuracy of both an electronic stethoscope and electrocardiogram (ECG) to evaluate heart rate in neonatal patients in the delivery suite.

The initial phase of this study will assess the electronic stethoscope use on stable neonates on the neonatal care prior to use in the delivery room.

Conditions

  • Premature Birth

Interventions

DEVICE

NICU electronic stethoscope

Assessment of heart rate using the electronic stethoscope for up to 10 minutes compared to ECG and pulse oximetry devices used to monitor neonates whilst on NICU

DEVICE

Newborns <32 weeks and ECG

The three leads from the ECG device will be pre placed onto a plastic bag prior to delivery. The pre term infant (\<32 weeks) placed into the bag at the time of delivery and heart rate will be assessed for up to 30 minutes

Sponsors & Collaborators

  • Heartlight Systems Limited

    collaborator INDUSTRY

  • University of Nottingham

    lead OTHER

Principal Investigators

  • Don Sharkey, PhD · University of Nottingham

Eligibility

Max Age
4 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-31
Primary Completion
2018-12-31
Completion
2018-12-31

Countries

  • United Kingdom

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 NCT02747069 on ClinicalTrials.gov