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.
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
- Conditions the study is for
- Infant, Newborn, Diseases, Fetus or Neonate Affected by Cesarean Section, Infant, Premature, Diseases
- 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
Show all 13Show fewer
- 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
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.
- Conditions
- Infant, Newborn, Diseases, Fetus or Neonate Affected by Cesarean Section, Infant, Premature, Diseases
- 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 group | Role | What they receive |
|---|---|---|
| NICU infants and hat | Newborn 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 sensor | Newborn 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 delivery | Well term newborn infants following birth by cesarean section. Receives: Device: The HeartLight hat with in-built sensor; Device: HeartLight; Device: HeartLight device | |
| Newborns needing stabilisation | Newborn infants requiring resuscitation or stabilisation following birth. Receives: Device: HeartLight; Device: HeartLight device | |
| Parental feedback | Parental feedback of babies recruited into HeartLight will be sought. Receives: Other: parental feedback | |
| Healthcare provider feedback | Healthcare 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.
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)
Reliability of heart rate generated by HeartLight device
Assess the reliability of the new heart rate device
Measured: 1 hour
Accuracy of heart rate generated by HeartLight device
Assess the accuracy of the new heart rate device
Measured: 1 hour
Feedback on acceptability of hat and device
Feedback will be recorded via a questionnaire from both healthcare professionals and mothers.
Measured: 1 hour
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
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.
- First posted8 Mar 2016 (estimated)
- Study startMar 2016
- Primary completionApr 2018
- Study completion11 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infant, Newborn, DiseasesStudies of the same condition, open and under way.
- More trials run by University of NottinghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Collaborators
- Heartlight Systems Limited
- Responsible party
- Sponsor
- Investigators
- Don Sharkey, PhD, Principal investigator, University of Nottingham
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
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HeartLight: Heart Rate Monitoring for Newborn Resuscitation
- ClinicalTrials.gov ID
- NCT02701920
- Acronym / sponsor ID
- HeartLight / 15099
- Conditions
- Infant, Newborn, Diseases, Fetus or Neonate Affected by Cesarean Section, Infant, Premature, Diseases
- Keywords
- Premature Birth, Infant, Heart rate
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 184 participants (actual)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Collaborators
- Heartlight Systems Limited
- Study start
- Mar 2016
- Primary completion
- Apr 2018 (actual)
- Study completion
- 11 May 2018 (actual)
- First posted
- 8 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| NICU infants and hat | – | Device: HeartLight hat, Device: The HeartLight hat with in-built sensorNewborn infants of any gestation on the neonatal intensive care unit (NICU). |
| NICU infants and sensor | – | Device: The HeartLight hat with in-built sensor, Device: HeartLight, Device: HeartLight deviceNewborn infants of any gestation requiring heart rate monitoring on the neonatal intensive care unit. |
| Newborns and surgical delivery | – | Device: The HeartLight hat with in-built sensor, Device: HeartLight, Device: HeartLight deviceWell term newborn infants following birth by cesarean section. |
| Newborns needing stabilisation | – | Device: HeartLight, Device: HeartLight deviceNewborn infants requiring resuscitation or stabilisation following birth. |
| Parental feedback | – | Other: parental feedbackParental feedback of babies recruited into HeartLight will be sought. |
| Healthcare provider feedback | – | Other: healthcare provider feedbackHealthcare professionals caring for babies recruited into HeartLight will have their feedback on the device sought. |
Who may qualify
- Ages
- Up to 4 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Infants
Key inclusion criteria (13 listed)
- Written consent from the mother
- Realistic prospect of survival as determined by the attending clinical team
- Infants on NICU
- Infants on NICU requiring heart rate monitoring
- Newborn infants following non-emergency elective cesarean section
Key exclusion criteria (13 listed)
- Infants undergoing palliative care
- Infants too sick to tolerate additional procedures
- Abnormal antenatal scans suggesting significant fetal abnormality (by definition these are not routine pregnancies).
- Any infant in whom resuscitation is likely to be required.
- If multiple births then only the first baby born shall be recruited (due to resource limitations with researchers attending the birth)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HeartLight hatHeartLight hat will be worn for up to 1 hour. | Device | NICU infants and hat |
| The HeartLight hat with in-built sensorThe HeartLight hat with in-built sensor will be worn. | Device | NICU infants and hat, NICU infants and sensor, Newborns and surgical delivery |
| HeartLightElectronic stethoscope will be used to estimate heart rate with HeartLight sensor/hat | Device | NICU infants and sensor, Newborns and surgical delivery, Newborns needing stabilisation |
| HeartLight deviceHeartLight sensor/hat will be used with ECG/Pulse oximetry/electronic stethoscope | Device | NICU infants and sensor, Newborns and surgical delivery, Newborns needing stabilisation |
| parental feedbackQuestionnaire | Other | Parental feedback |
| healthcare provider feedbackQuestionnaire | Other | Healthcare provider feedback |
Primary outcome
Heart Rate acquisition time in the first minute of life
Time frame: 1 hour
Time to acquire heart rate from new optical hat sensor from birth should be within 1 minute of birth.
5 secondary outcomes
Reliability of heart rate generated by HeartLight device
Time frame: 1 hour
Accuracy of heart rate generated by HeartLight device
Time frame: 1 hour
Feedback on acceptability of hat and device
Time frame: 1 hour
Thermal imaging to determine heat loss whilst wearing hat
Time frame: 1 hour
Thermal imaging to determine heat loss during stabilisation and/or resuscitation
Time frame: 1 hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2018.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Don Sharkey, PhD principal investigator
University of Nottingham
1 site in 1 country: see every site and its status.
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.