Heart Beat Study – Version 1

• Research type

  Research Study

• Full title

  Improving early decisions in neonatal encephalopathy by monitoring heart beat variability (HeartBeat Study)

• IRAS ID

  225735

• Contact name

  Sudhin Thayyil

• Contact email

  s.thayyil@imperial.ac.uk

• Sponsor organisation

  Imperial College London

• Duration of Study in the UK

  4 years, 0 months, 0 days

• Research summary

  Research Summary
  Aim:
  The main aim of this study will find out if analysis of minute changes in heart trace in babies with brain injury, can inform treatment decisions and monitor stress levels in real time

  Background:
  Although cooling therapy reduces brain injury and improves outcomes after birth asphyxia, it is difficult to identify all babies who need this treatment, soon after birth. Even when we do correctly identify babies needing treatment, treatment becomes ineffective if the baby is stressed. Minimising stress may be possible with skilled nursing care or sedation, but there are no effective ways of real-time stress monitoring in babies at present.

  Methods:
  We will prospectively enroll 140 term babies with birth asphyxia, from Magnetic Resonance Biomarker Consortium centres (Medway Hospital, Coventry Hospital, Norwich Hospital, Royal Victoria Infirmary, Newcastle and Imperial NHS Trust), over a 2 year period. We will collect continuous ECG data (starting within 6 hours of age), hourly clinical pain scores, and 12 hourly salivary cortisol (a marker of stress) for the first 5 days from all recruited babies. Specific features of heart rate variability we be calculated using our in-house tools. These babies will also have MRI scan within two weeks after birth and a neurodevelopmental examination at 18 months of age, as part of clinical care. In addition, we will recruit 100 healthy newborn babies to understand the normal changes in heart trace that happens soon after birth.

  Outcomes
  We will then examine the accuracy of early heart rate variability (obtained within six hours of age) in identifying babies with perinatal asphyxia, who are at risk of brain injury and adverse neurodevelopmental outcomes. We will also examine if the late heart rate variability (six hours to 5 days) indices can identify stress in these babies, by comparing with cortisol levels and other pain scores.

  Lay summary of study results
  https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fu2790089.ct.sendgrid.net%2Fls%2Fclick%3Fupn%3DXv3JSvJ-2B3M71ppf7N9agbQne05VVe0UaW9iiRd6kqFqddEKGSwaTDMwJ3m69QjYIGQcPmUBXDRIAwLXGTCVSQA-3D-3D-WkK_E1aO2-2BZlVOSJJV-2FajQqskegTd6IRomHYTi-2Fbt8SH3YJmuiWrzHhdfvU3pmmat-2BilQO9YeVYJTfWyDRoxzGOpQjvtM6jR9z4J-2BHX1OQeIEsOpqjcfE4jjY6FYI4-2FEHu0pACVXfyHox361KG-2Fbor5r0lQkayvL2InJFbwePbGuq6bBjB1Py4dDip0-2FwtwvKQkvVJtta-2FzwqIR4esRutuOasg-3D-3D&data=05%7C01%7Cchelsea.rec%40hra.nhs.uk%7Cae6fcd7d8c1540fff32a08dbce40e80c%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638330550383559129%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=JmSNJH0Lw9Pnh4Twa1lumkn6YGsvmDCNUMRDAYSWuIs%3D&reserved=0

• REC name

  London - Chelsea Research Ethics Committee

• REC reference

  17/LO/0956

• Date of REC Opinion

  22 Jun 2017

• REC opinion

  Favourable Opinion