Heart Beat Variability in Neonatal Encephalopathy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

210 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-08-15

Study Completion Date

2025-11-28

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Neonatal Encephalopathy Asphyxia Neonatorum Hypoxic-Ischemic Encephalopathy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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HIE

Babies admitted to the neonatal unit with suspected mild, moderate or severe hypoxic ischaemic encephalopathy .

No interventions assigned to this group

Healthy

Babies who are inpatients in the postnatal ward, born following uncomplicated pregnancy and delivery.

No interventions assigned to this group

Eligibility Criteria

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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

* 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 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

Minimum Eligible Age

0 Hours

Maximum Eligible Age

6 Hours

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes