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Infant, Newborn, DiseasesHeartLightNCT02701920

HeartLight: Heart Rate Monitoring for Newborn Resuscitation

An observational study of Infant, Newborn, Diseases and Fetus or Neonate Affected by Cesarean Section, run by University of Nottingham at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study will compare a newborn heart rate sensor (HeartLight) that is integrated into a hat with other common forms of heart rate monitoring such as electrocardiography (ECG), stethoscope and pulse oximetry (PO) in newborn babies. This will help to evaluate the new heart rate sensor's reliability and accuracy. Read more about this study

Who is it for?
Ages Up to 4 months
What is being tested?
HeartLight hat, The HeartLight hat with in-built sensor and HeartLight
Type of treatment
Medical device
How many people
184 participants
Where
1 siteUnited Kingdom
Study dates
Mar 2016to 11 May 2018
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 4 months
  • All sexes
  • No healthy volunteers
  • Child

Study population: Infants

Who may be able to join

  • Written consent from the mother
  • Realistic prospect of survival as determined by the attending clinical team
  • Phase 1:
  • Infants on NICU
  • Phase 2:
  • Infants on NICU requiring heart rate monitoring
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  • Phase 3:
  • Newborn infants following non-emergency elective cesarean section
  • Phase 4:
  • Newborn infants who attending clinical team anticipate will require assessment of heart rate at time of birth
  • Feedback:
  • Mothers of babies recruited into HeartLight study
  • Healthcare professionals exposed to the new device

Who cannot join

  • Phase 1+2:
  • Infants undergoing palliative care
  • Infants too sick to tolerate additional procedures
  • Phase 3:
  • Abnormal antenatal scans suggesting significant fetal abnormality (by definition these are not routine pregnancies).
  • Any infant in whom resuscitation is likely to be required.
Show all 13Show fewer
  • If multiple births then only the first baby born shall be recruited (due to resource limitations with researchers attending the birth)
  • Phase 4:
  • Infants <23 weeks
  • Infants that are not for active resuscitation as decided by the clinical team
  • If multiple births then only the first baby born shall be recruited (due to resource limitations with researchers attending the birth)
  • Feedback:
  • Unable to obtain written informed consent

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site
  • University of Nottingham NHS Trust

    Nottingham, NG72UH

Other trials in United Kingdom

About this study

This study will compare a newborn heart rate sensor (HeartLight) that is integrated into a hat with other common forms of heart rate monitoring such as electrocardiography (ECG), stethoscope and pulse oximetry (PO) in newborn babies. This will help to evaluate the new heart rate sensor's reliability and accuracy.

Read the detailed description

Up to 10% of newborns require some form of resuscitation at birth. Heart rate (HR) is the most sensitive indicator of resuscitation efficacy. HR is most commonly estimated using a stethoscope. However, in simulation studies it has been shown that newborn healthcare providers estimate HR incorrectly in up to 1/3 of cases. Common techniques for monitoring heart rate such as electrocardiography (ECG) and pulse oximetry (PO) were not developed for resuscitation at birth.

ECG, an established and accurate method of monitoring HR, is rarely used in the delivery room for a number of reasons including difficulty ensuring adhesion to the skin (the baby is wet/covered in vernix) and skin damage in premature babies caused by stripping of the electrodes. Current ECG systems also require 3 electrodes to be positioned which can delay resuscitation further. The usual site for transmission PO is the foot or hand. However, in newborn babies, and particularly those requiring resuscitation when the HR is low, blood flow is reduced so physiological mechanisms preserve brain and heart blood flow at the expense of other less important organs and limbs. As a consequence of this and the choice of wavelengths, it can be more difficult to obtain a reliable HR from POs on the limbs, and they typically obtain an HR after 1-2 minutes.

In the delivery room, ECG and PO systems have a requirement for cables to connect to the main monitors. These can get in the way and it is now recommended for many babies to delay cutting the umbilical cord (to ensure more blood enters the baby from the placenta) which often requires the baby to be resuscitated very close to the mother and even between their legs.

The HeartLight system is a wireless optical sensor within a custom newborn hat to allow quick and accurate HR monitoring. It will be compared to ECG, PO and electronic stethoscope to determine the accuracy and reliability. The trial has 4 phases; Phase 1 evaluates the thermal properties of the hat, Phase 2 evaluates the accuracy and reliability of the HeartLight sensor on babies within the Neonatal Intensive Care Unit environment, Phase 3 evaluates the HeartLight sensor in newborn babies born by cesarean section and Phase 4 evaluates the performance of the HeartLight sensor in babies of all gestations requiring resuscitation and stabilisation at birth.

The investigators anticipate the HeartLight sensor and hat will allow swift and effective deployment, reduce delays in resuscitation (due to using a stethoscope) and improve HR accuracy (as a result of avoiding errors in the usual manual mental calculations made in the stressful environment of the delivery room) when it is needed most. However, an additional benefit is that it will not require significant modification to the existing care pathway or resuscitation protocols, and therefore a potential barrier to clinical uptake is removed.

Being tested
HeartLight hat, The HeartLight hat with in-built sensor, HeartLight, HeartLight device, parental feedback
Keywords
Premature Birth, Infant, Heart rate
Medical subject headings
Infant, Newborn, Diseases, Infant, Premature, Diseases, Premature Birth

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HeartLight hatDevice

    HeartLight hat will be worn for up to 1 hour.

  • The HeartLight hat with in-built sensorDevice

    The HeartLight hat with in-built sensor will be worn.

  • HeartLightDevice

    Electronic stethoscope will be used to estimate heart rate with HeartLight sensor/hat

  • HeartLight deviceDevice

    HeartLight sensor/hat will be used with ECG/Pulse oximetry/electronic stethoscope

  • parental feedbackOther

    Questionnaire

  • healthcare provider feedbackOther

    Questionnaire

Study groups in NCT02701920
Study groupRoleWhat they receive
NICU infants and hatNewborn infants of any gestation on the neonatal intensive care unit (NICU).
Receives: Device: HeartLight hat; Device: The HeartLight hat with in-built sensor
NICU infants and sensorNewborn infants of any gestation requiring heart rate monitoring on the neonatal intensive care unit.
Receives: Device: The HeartLight hat with in-built sensor; Device: HeartLight; Device: HeartLight device
Newborns and surgical deliveryWell term newborn infants following birth by cesarean section.
Receives: Device: The HeartLight hat with in-built sensor; Device: HeartLight; Device: HeartLight device
Newborns needing stabilisationNewborn infants requiring resuscitation or stabilisation following birth.
Receives: Device: HeartLight; Device: HeartLight device
Parental feedbackParental feedback of babies recruited into HeartLight will be sought.
Receives: Other: parental feedback
Healthcare provider feedbackHealthcare professionals caring for babies recruited into HeartLight will have their feedback on the device sought.
Receives: Other: healthcare provider feedback

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Heart Rate acquisition time in the first minute of life

    Time to acquire heart rate from new optical hat sensor from birth should be within 1 minute of birth.

    Measured: 1 hour

Secondary outcomes (5)
  1. Reliability of heart rate generated by HeartLight device

    Assess the reliability of the new heart rate device

    Measured: 1 hour

  2. Accuracy of heart rate generated by HeartLight device

    Assess the accuracy of the new heart rate device

    Measured: 1 hour

  3. Feedback on acceptability of hat and device

    Feedback will be recorded via a questionnaire from both healthcare professionals and mothers.

    Measured: 1 hour

  4. Thermal imaging to determine heat loss whilst wearing hat

    Participants will be thermal imaged whilst wearing the hat to determine heat loss.

    Measured: 1 hour

  5. Thermal imaging to determine heat loss during stabilisation and/or resuscitation

    Participants will be thermal imaged during stabilisation and/or resuscitation whilst wearing the hat to determine heat loss.

    Measured: 1 hour

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Mar 2016 (estimated)
  2. Study startMar 2016
  3. Primary completionApr 2018
  4. Study completion11 May 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
184 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02701920
Sponsor's protocol ID
15099
Acronym
HeartLight
Status last verified
Sep 2016
First submitted
25 Feb 2016
Last updated
17 May 2018
Results posted
No
Data monitoring committee
No
Individual data sharing
Yes

Questions about this trial

What is this clinical trial studying?

An observational study of Infant, Newborn, Diseases and Fetus or Neonate Affected by Cesarean Section, run by University of Nottingham at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 May 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Heart Rate acquisition time in the first minute of life (time frame: 1 hour). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2018.

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