Heart Beat Variability in Neonatal Encephalopathy

NCT03179553 | Active Not Recruiting

• 1 other identifier: 17HH3917
• Study Type: observational
• Target: 210
• Locations: 1 country
• Sites: 5

Brief 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

Conditions

Neonatal Encephalopathy; Asphyxia Neonatorum; Hypoxic-Ischemic Encephalopathy

Outcome Measures

Primary Outcomes (1)

• 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

  18-22months

Secondary Outcomes (1)

• Correlation between HRV and salivary cortisol levels

  first 5 days of live

Study Arms (2)

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.

Eligibility Criteria

• Age: 0 Hours - 6 Hours
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Newborn babies within 6h of birth, healthy or with neonatal encephalopathy (mild, moderate or severe)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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
• Babies requiring any medication or phototherapy
• Perinatal maternal fever

Sponsors & Collaborators

• Imperial College London: lead

Study Sites (5)

University Hospital Coventry & Warickshire NHS Trust

Coventry, United Kingdom

Location

Medway NHS Foundation Trust

Gillingham, United Kingdom

Location

Imperial College Healthcare NHS Trust

London, United Kingdom

Location

The Newcastle Upon Tyne NHS Foundation Trust

Newcastle, United Kingdom

Location

Norfolk & Norwich University Hospitals NHS Foundation Trust

Norwich, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITH DNA

salivary swabs for cortisol measurements.

MeSH Terms

Conditions

Asphyxia Neonatorum; Hypoxia-Ischemia, Brain

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Brain Ischemia; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hypoxia, Brain; Vascular Diseases; Cardiovascular Diseases; Hypoxia; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Sudhin Thayyil

  Imperial College London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2017
• First Posted: June 7, 2017
• Study Start: August 15, 2017
• Primary Completion: August 28, 2023
• Study Completion: November 28, 2025
• Last Updated: March 19, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (5)