- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03179553
Heart Beat Variability in Neonatal Encephalopathy (HeartBeat)
Improving Early Decisions in Neonatal Encephalopathy by Monitoring Heartbeat Variability
Study Overview
Status
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Ismita Chhetri, PhD
- Phone Number: 00442033132473
- Email: i.chhetri@imperial.ac.uk
Study Contact Backup
- Name: Sudhin S Thayyil
- Phone Number: 00442033132473
- Email: s.thayyil@imperial.ac.uk
Study Locations
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Coventry, United Kingdom
- University Hospital Coventry & Warickshire NHS Trust
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Gillingham, United Kingdom
- Medway NHS Foundation Trust
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London, United Kingdom
- Imperial College Healthcare NHS Trust
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Newcastle, United Kingdom
- The Newcastle Upon Tyne NHS Foundation Trust
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Norwich, United Kingdom
- Norfolk & Norwich University Hospitals NHS Foundation Trust
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
HIE COHORT
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Inclusion criteria:
- 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
Exclusion criteria
- Babies requiring any medication or phototherapy
- Perinatal maternal fever
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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HIE
Babies admitted to the neonatal unit with suspected mild, moderate or severe hypoxic ischaemic encephalopathy .
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Healthy
Babies who are inpatients in the postnatal ward, born following uncomplicated pregnancy and delivery.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Prognostic accuracy of HRV to predict adverse neurodevelopment outcome
Time Frame: 18-22months
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Various linear and non-linear HRV indices will be compared with neurodevelopment at 18 to 22 months
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18-22months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Correlation between HRV and salivary cortisol levels
Time Frame: first 5 days of live
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Various linear and non-linear HRV indices will be compared cortisol levels (measure of stress)
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first 5 days of live
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sudhin Thayyil, Imperial College London
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Cardiovascular Diseases
- Vascular Diseases
- Cerebrovascular Disorders
- Central Nervous System Diseases
- Nervous System Diseases
- Wounds and Injuries
- Infant, Newborn, Diseases
- Signs and Symptoms, Respiratory
- Death
- Hypoxia
- Hypoxia, Brain
- Brain Ischemia
- Brain Diseases
- Hypoxia-Ischemia, Brain
- Asphyxia
- Asphyxia Neonatorum
Other Study ID Numbers
- 17HH3917
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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