Outcome of infants cooled for HIE exposed to infection

• Research type

  Research Study

• Full title

  Data intensive research using national database: Predictors of adverse outcome in cooled infants with hypoxic-ischaemic encephalopathy and perinatal infection

• IRAS ID

  245357

• Contact name

  Ela Chakkarapani

• Contact email

  ela.chakkarapani@bristol.ac.uk

• Sponsor organisation

  University of Bristol

• Duration of Study in the UK

  0 years, 6 months, 0 days

• Research summary

  Each year about 1200 babies in England, Wales and Scotland suffer a lack of oxygen around birth which leads to death or long-term brain injury and disabilities in the survivors. This condition is called Hypoxic-ischaemic encephalopathy (HIE). Cooling babies with HIE by 3 degrees centigrade for three days reduces the risk of death or disabilities. However, around 40-50% of cooled infants still suffer death or disabilities. Reasons for this lack of response to cooling therapy in these babies is not clear.
  Experimental studies show that cooling therapy may not reduce brain injuries in animals that were exposed to certain types of bacterial infection before exposure to lack of oxygen. It is unknown whether babies with HIE exposed to infection before birth respond to cooling therapy. Some of these babies will have bacteria isolated from the blood and are shown to be at a higher risk of death.
  In this study, the research team will study the outcomes of death or feeds given through a nasal tube at discharge to home. Other outcomes including length of hospital stay, the day of life when full oral feeding was established with breast or formula milk, bleeding in the brain, fits and multiple organ impairments. The research team will compare these outcomes between the cooled babies who have been exposed to infection before birth or have a bacterial infection in the blood and those who have not. The research team will use a research database called the National Neonatal Research Database (NNRD) and a statistical approach called generalised linear model to ensure that any difference in outcomes is due to the infection status and not due to the severity of illness of the baby.

• REC name

  North West - Greater Manchester East Research Ethics Committee

• REC reference

  18/NW/0377

• Date of REC Opinion

  14 May 2018

• REC opinion

  Favourable Opinion