Background and eligibility


Background and eligibility

The study is to test whether a drug called erythropoietin (Epo) improves survival and decreases the chance of disability in babies who have hypoxic ischaemic encephalopathy, or HIE. HIE occurs when there is low oxygen and/or low blood supply to the brain and may result in brain damage, disability or even death. Epo is not an approved treatment for HIE in Australia or elsewhere. This means its use in this study is experimental.

 

Who is eligible?

Term or near-term infants (≥ 35+0 weeks of gestation) with moderate or severe HIE in which hypothermia treatment (controlled whole-body cooling to a target temperature, either adjusted manually or with a device) is initiated by 6 hours of age. Informed consent should be received from a parent. 

There will be some hospital assessments to ensure the baby can participate in this study and this information will be collected once the parent approves. 

 

Who may not be eligible? 

Babies who have received Epo for another reason before participating in the study or cannot receive Epo in the doctor's opinion. Other reasons include a congenital malformation, if the baby is too small or too unwell. 

 

Follow up 

The study will keep in touch with family to find out about each baby's progress through routine follow-up appointments as part of their standard care and treatment. Additional assessments include: 

  • General movements assessment at 12 weeks of age
  • 6 monthly review of health service utilisation and child's health up to 2 years of age
  • 2 year assessments including: Bayleys Scales of Infant Development III, paediatric assessment, M-CHAT questionnaire and Medicare records access. 

The study will keep in touch with parents via phone calls, email and post to send updates, birthday wishes and generally for the study to maintain contact. 

Subject to funding we will keep in touch with children up to 8 years of age.

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Participating sites

Australia

  • Mater Mothers' Hospital, QLD
  • John Hunter Hospital, NSW
  • Royal Prince Alfred Hospital, NSW
  • Nepean Hospital, NSW
  • Royal North Shore Hospital, NSW
  • The Royal Children's Hospital, VIC
  • Women and Children's Hospital, SA
  • Flinders Medical Centre, SA
  • King Edward Memorial Hospital, WA
  • Princess Margaret Hospital, WA
  • Canberra Hospital, ACT
  • The Children's Hospital at Westmead, NSW
  • The Royal Women's Hospital, VIC

 

New Zealand

  • Waikato Hospital
  • Middlemore Hospital
  • Auckland Hospital