Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT03179553 |
| Other study ID # |
17HH3917 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
August 15, 2017 |
| Est. completion date |
November 28, 2025 |
Study information
| Verified date |
March 2024 |
| Source |
Imperial College London |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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
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.
