NCT02747069

Brief 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.

Trial Health

33
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 25, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 21, 2016

Completed
10 days until next milestone

Study Start

First participant enrolled

May 1, 2016

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

May 17, 2018

Status Verified

May 1, 2018

Enrollment Period

2.6 years

First QC Date

February 25, 2016

Last Update Submit

May 11, 2018

Conditions

Premature Birth

Keywords

Heart rateElectronic StethoscopeElectrocardiogramResuscitation

Outcome Measures

Primary Outcomes (2)

  • Heart rate

    Assessment of accuracy (limits of agreement ±10bpm at 2 standard deviations) and reliability (\>90% agreement +/- 10 bpm) of an electronic stethoscope to measure heart rate when compared to ECG.

    10 minutes

  • Reliability of Pre placed ECG leads to measure heart rate

    Assess of the reliability of pre-placed ECG to measure heart rate at the time of delivery when compared to heart rate assessed by an electronic stethoscope.

    30 minutes

Secondary Outcomes (2)

  • Accuracy of Clinical assessment of heart rate using an electronic stethoscope

    30 minutes

  • Acquisition of video recorded resuscitation of newborns for clinical feedback

    30 minutes

Study Arms (2)

NICU electronic stethoscope

Neonatal patients of any gestation admitted to the neonatal intensive care unit (NICU) and undergoing routine monitoring with ECG and pulse oximetry Heart rate will be evaluated using an electronic stethoscope

Device: NICU electronic stethoscope

Newborns <32 weeks and ECG

Neonatal patients \<32 weeks gestation Heart rate will be assessed at the time of delivery with both an electronic stethoscope and ECG using a pre placed lead system

Device: NICU electronic stethoscopeDevice: Newborns <32 weeks and ECG

Interventions

NICU electronic stethoscopeDEVICE

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

NICU electronic stethoscopeNewborns <32 weeks and ECG
Newborns <32 weeks and ECGDEVICE

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

Newborns <32 weeks and ECG

Eligibility Criteria

AgeUp to 4 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Phase 1- neonates of any gestation admitted to NICU with routine ECG and pulse oximetry monitoring

You may qualify if:

  • All must have written informed consent from the participant's mother
  • Phase 1: Any neonate requiring NICU admission and routine monitoring with ECG.
  • Phase 2: Preterm infants ≤32 weeks gestation delivered into a plastic bag/wrap

You may not qualify if:

  • Phase 1: Infants undergoing comfort care (palliative care). Infants deemed too sick, as assessed by the clinical team caring for them, to tolerate additional procedures. This is unusual but would normally include infants who become more unstable with increased handling
  • Phase 2: Infants \>32 weeks gestation Infants where resuscitation is unlikely to be instigated (eg. known lethal condition)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Nottingham NHS Trust

Nottingham, NG72UH, United Kingdom

Location

MeSH Terms

Conditions

Premature Birth

Interventions

Electrocardiography

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

Heart Function TestsDiagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosisElectrodiagnosis

Study Officials

  • Don Sharkey, PhD

    University of Nottingham

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 25, 2016

First Posted

April 21, 2016

Study Start

May 1, 2016

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

May 17, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will share

Locations

GB(1)