Neonatal EncephalopathyHeartBeatNCT03179553
Heart Beat Variability in Neonatal Encephalopathy
An observational study of Neonatal Encephalopathy and Asphyxia Neonatorum, run by Imperial College London at 5 sites in United Kingdom.
Trial summary
This study will find out if analysing heartbeat in babies with brain injury, based on standard clinical monitors, can inform treatment decisions and monitor stress levels in real time Read more about this study
- Who is it for?
- Ages 0 to 6 hoursHealthy volunteers can take part
- Conditions the study is for
- Neonatal Encephalopathy, Asphyxia Neonatorum, Hypoxic-Ischemic Encephalopathy
- How many people
- 210 participants
- Where
- 5 sitesUnited Kingdom
- Study dates
- 15 Aug 2017to 28 Nov 2025
- 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 0 to 6 hours
- All sexes
- Healthy volunteers accepted
- Child
Study population: Newborn babies within 6h of birth, healthy or with neonatal encephalopathy (mild, moderate or severe)
Who may be able to join
- Full term babies (>36 weeks)
- Requiring resuscitation at birth due to perinatal asphyxia and/or 5 minute Apgar score <6.
- Structured clinical neurological examination (modified Sarnat stage) within six hours of age suggestive of encephalopathy (mild, moderate or severe)
- Age less than six hours at the time of admission to the neonatal unit
- Healthy full term babies (>36 weeks) and birth weight between 9th to 91st centile
- Age less than six hours at the time of study enrolment
Who cannot join
- Babies with lethal congenital malformations or cardiac conditions that could affect heartbeat variability
- Participation in any controlled trials of investigational medical products (C-TIMPS)
- HEALTHY COHORT
- Babies requiring any medication or phototherapy
- Perinatal maternal fever
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United Kingdom5 sites
University Hospital Coventry & Warickshire NHS Trust
Coventry
Medway NHS Foundation Trust
Gillingham
Imperial College Healthcare NHS Trust
London
The Newcastle Upon Tyne NHS Foundation Trust
Newcastle
Norfolk & Norwich University Hospitals NHS Foundation Trust
Norwich
About this study
Official title: Improving Early Decisions in Neonatal Encephalopathy by Monitoring Heartbeat Variability
This study will find out if analysing heartbeat in babies with brain injury, based on standard clinical monitors, can inform treatment decisions and monitor stress levels in real time
Read the detailed description
BACKGROUND
Hypoxic ischaemic encephalopathy (HIE) is the single most common cause of death and lifelong neurodisability in term babies. Although cooling treatment improves outcomes for these babies, early identification (within six hours of birth) of 'at risk infants' remains challenging. Consequently, not all babies who need treatment will receive it and other babies receive treatment unnecessarily. Furthermore, neuroprotection from cooling may be lost if baby remains stressed during treatment, but accurate methods of measuring stress in babies are lacking.
AIMS
Primary aim:
To examine the accuracy of heartbeat variability (HRV), within six hours of birth, to predict adverse neurodevelopmental outcome at 18 to 22 months in encephalopathic babies.
Secondary aims:
- To examine the relation between heartbeat variability and stress in encephalopathic babies.
- To identify clinical interventions associated with reduced heartbeat variability in encephalopathic babies.
- To describe the trajectory of normal heartbeat variability changes in healthy term babies during the first 24 hours after birth.
METHODS
A total 140 term babies with hypoxic ischaemic encephalopathy will be recruited. The investigators will collect continuous electrocardiography (ECG) data, hourly Neonatal Pain Agitation and Sedation Scale (NPASS) and 12 hourly salivary cortisol, for the first five days after birth. Various clinical interventions, and noise and light levels that the baby is exposed to, for the first 5 days after birth will be be recorded.
The investigators will analyse the raw ECG using Matlab® with in-house algorithms to quantify specific linear and non-linear measures of HRV. All recruited encephalopathic babies will have brain magnetic resonance (MR) imaging and spectroscopy using harmonised protocols and neurodevelopmental assessment, as a part of clinical care, or as a part of MR biomarker studies. This data will be collected and used for the Heartbeat study to examine the association between heart rate variability with brain injury and neurodevelopmental outcome.
In addition, the investigators will collect the ECG data from 100 healthy term babies for the first 24 hours after birth, to describe the trajectory of normal heartbeat variability in healthy term babies.
DATA ANALYSIS AND OUTCOME MEASURES
The prognostic accuracy (sensitivity, specificity, 95% confidence intervals) of early heartbeat variability using optimal cut-off values will be reported for the primary outcome. Logistic regression models adjusted for potential confounders will be used to report secondary outcomes.
POTENTIAL BENEFIT TO PATIENTS
Once the most accurate HRV indices and thresholds are identified, this data can be readily incorporated into a bed side real-time monitoring device. This device may have several clinical implications, including (i) improving access to treatment and the number of babies who benefit from being offered cooling; (ii) avoiding cooling therapy to low risk infants with hypoxic ischaemic encephalopathy (iii) maximising the therapeutic effect of cooling by reducing stress; (iv) enabling tailored neonatal nursing care based on real-time monitoring of neonatal stress and thus improving the long-term outcomes of babies with hypoxic ischaemic encephalopathy.
- Medical subject headings
- Asphyxia Neonatorum, Hypoxia-Ischemia, Brain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| HIE | Babies admitted to the neonatal unit with suspected mild, moderate or severe hypoxic ischaemic encephalopathy . | |
| Healthy | Babies who are inpatients in the postnatal ward, born following uncomplicated pregnancy and delivery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prognostic accuracy of HRV to predict adverse neurodevelopment outcome
Various linear and non-linear HRV indices will be compared with neurodevelopment at 18 to 22 months
Measured: 18-22months
Secondary outcomes (1)
Correlation between HRV and salivary cortisol levels
Various linear and non-linear HRV indices will be compared cortisol levels (measure of stress)
Measured: first 5 days of live
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2017
- Study start15 Aug 2017
- Primary completion28 Aug 2023
- Study completion28 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neonatal EncephalopathyStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe 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
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sudhin Thayyil, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03179553
- Sponsor's protocol ID
- 17HH3917
- Acronym
- HeartBeat
- Status last verified
- Mar 2024
- First submitted
- 6 Jun 2017
- Last updated
- 19 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Early Decisions in Neonatal Encephalopathy by Monitoring Heartbeat Variability
- ClinicalTrials.gov ID
- NCT03179553
- Acronym / sponsor ID
- HeartBeat / 17HH3917
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- 15 Aug 2017 (actual)
- Primary completion
- 28 Aug 2023 (actual)
- Study completion
- 28 Nov 2025 (estimated)
- First posted
- 7 Jun 2017 (actual)
- 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 find out if analysing heartbeat in babies with brain injury, based on standard clinical monitors, can inform treatment decisions and monitor stress levels in real time
Detailed description
BACKGROUND
Hypoxic ischaemic encephalopathy (HIE) is the single most common cause of death and lifelong neurodisability in term babies. Although cooling treatment improves outcomes for these babies, early identification (within six hours of birth) of 'at risk infants' remains challenging. Consequently, not all babies who need treatment will receive it and other babies receive treatment unnecessarily. Furthermore, neuroprotection from cooling may be lost if baby remains stressed during treatment, but accurate methods of measuring stress in babies are lacking.
AIMS
Primary aim:
To examine the accuracy of heartbeat variability (HRV), within six hours of birth, to predict adverse neurodevelopmental outcome at 18 to 22 months in encephalopathic babies.
Secondary aims:
- To examine the relation between heartbeat variability and stress in encephalopathic babies.
- To identify clinical interventions associated with reduced heartbeat variability in encephalopathic babies.
- To describe the trajectory of normal heartbeat variability changes in healthy term babies during the first 24 hours after birth.
METHODS
A total 140 term babies with hypoxic ischaemic encephalopathy will be recruited. The investigators will collect continuous electrocardiography (ECG) data, hourly Neonatal Pain Agitation and Sedation Scale (NPASS) and 12 hourly salivary cortisol, for the first five days after birth. Various clinical interventions, and noise and light levels that the baby is exposed to, for the first 5 days after birth will be be recorded.
The investigators will analyse the raw ECG using Matlab® with in-house algorithms to quantify specific linear and non-linear measures of HRV. All recruited encephalopathic babies will have brain magnetic resonance (MR) imaging and spectroscopy using harmonised protocols and neurodevelopmental assessment, as a part of clinical care, or as a part of MR biomarker studies. This data will be collected and used for the Heartbeat study to examine the association between heart rate variability with brain injury and neurodevelopmental outcome.
In addition, the investigators will collect the ECG data from 100 healthy term babies for the first 24 hours after birth, to describe the trajectory of normal heartbeat variability in healthy term babies.
DATA ANALYSIS AND OUTCOME MEASURES
The prognostic accuracy (sensitivity, specificity, 95% confidence intervals) of early heartbeat variability using optimal cut-off values will be reported for the primary outcome. Logistic regression models adjusted for potential confounders will be used to report secondary outcomes.
POTENTIAL BENEFIT TO PATIENTS
Once the most accurate HRV indices and thresholds are identified, this data can be readily incorporated into a bed side real-time monitoring device. This device may have several clinical implications, including (i) improving access to treatment and the number of babies who benefit from being offered cooling; (ii) avoiding cooling therapy to low risk infants with hypoxic ischaemic encephalopathy (iii) maximising the therapeutic effect of cooling by reducing stress; (iv) enabling tailored neonatal nursing care based on real-time monitoring of neonatal stress and thus improving the long-term outcomes of babies with hypoxic ischaemic encephalopathy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HIE | – | –Babies admitted to the neonatal unit with suspected mild, moderate or severe hypoxic ischaemic encephalopathy . |
| Healthy | – | –Babies who are inpatients in the postnatal ward, born following uncomplicated pregnancy and delivery. |
Who may qualify
- Ages
- 0 to 6 hours
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Newborn babies within 6h of birth, healthy or with neonatal encephalopathy (mild, moderate or severe)
Key inclusion criteria (6 listed)
- Full term babies (>36 weeks)
- Requiring resuscitation at birth due to perinatal asphyxia and/or 5 minute Apgar score <6.
- Structured clinical neurological examination (modified Sarnat stage) within six hours of age suggestive of encephalopathy (mild, moderate or severe)
- Age less than six hours at the time of admission to the neonatal unit
- Healthy full term babies (>36 weeks) and birth weight between 9th to 91st centile
Key exclusion criteria (5 listed)
- Babies with lethal congenital malformations or cardiac conditions that could affect heartbeat variability
- Participation in any controlled trials of investigational medical products (C-TIMPS)
- HEALTHY COHORT
- Babies requiring any medication or phototherapy
- Perinatal maternal fever
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prognostic accuracy of HRV to predict adverse neurodevelopment outcome
Time frame: 18-22months
Various linear and non-linear HRV indices will be compared with neurodevelopment at 18 to 22 months
1 secondary outcome
Correlation between HRV and salivary cortisol levels
Time frame: first 5 days of live
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2024.
- Individual participant dataSharing planned: No
Related trials for Neonatal Encephalopathy
Not yet recruiting
Levetiracetam as an Adjuvant Therapy to Hypothermia in Neonatal Asphyxia
Hypoxic Ischemic Encephalopathy of Newborn, Neuro-protection
RecruitingPhase 2
The PROTECT-HIE Pilot Trial
Hypoxic-ischemic Encephalopathy (HIE)
RecruitingObservational study
The NIH MINI Study: Metabolism, Infection, and Immunity in Inborn Errors of Metabolism
Oxidative Phosphorylation Deficiencies, Electron Transport Chain Disorders, Mitochondrial
RecruitingPhase 2
A Dose Escalation Study of Levetiracetam in the Treatment of Neonatal Seizures
Neonatal Seizure, Neonatal Encephalopathy
Enrolling by invitationPhase 3
A Study to Investigate LP352 in Children and Adults With Developmental and Epileptic Encephalopathy (DEE)
Developmental and Epileptic Encephalopathy
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.
Sudhin Thayyil principal investigator
Imperial College London
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neonatal Encephalopathy and Asphyxia Neonatorum, run by Imperial College London at 5 sites 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 6 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 19 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
Results are not available in the source record.
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?
Prognostic accuracy of HRV to predict adverse neurodevelopment outcome (time frame: 18-22months). 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 19 Mar 2024.