What is PAEAN?
A lack of oxygen (hypoxia) or low blood supply (ischaemia)
before or during birth can destroy cells in a newborn baby's brain.
The damage caused by the lack of oxygen continues for some time
afterwards. One way to try to reduce this damage is to induce
hypothermia cooling the baby or just the baby's head for hours to
days. Erythropoietin (Epo) given in the first week after birth
shows promise as a treatment that may also help. This study is to
find out whether Epo plus induced hypothermia (cooling) of near
term newborn babies who have suffered from low blood or oxygen
supply to the brain at birth reduces death and disability in
survivors at two years of age.
PAEAN stands for Preventing Adverse Outcomes of Neonatal Hypoxic
Ischaemic Encephalopathy with Erythropoietin
What are the study
Current treatment for babies with HIE is to lower the baby's
body temperature (cool) for 3 days to minimise brain damage. Even
with cooling, nearly one in two infants either will not survive or
will survive with major disability.
When babies are enrolled to the trial in addition to standard
cooling treatment, they will receive either:
Placebo treatment. The placebo treatment will be saline (dilute
salt water) which looks like Epo but has no active ingredients and
does not cause any harm.
What are we trying to find out?
Treatment with Epo might reduce brain injury. We hope this study
will improve medical knowledge and treatment of babies with HIE in
future. After your baby's discharge from hospital, we will keep in
touch with you about your baby's progress. Your baby will have
routine follow-up appointments as part of their standard care and
How many babies are taking
Current recruitment total: 26 (as of December 2016)
Recruitment target: 300
Coordination, sponsorship and
This multicentre trial is coordinated by CTC
and is sponsored by the University of Sydney. Funding is provided
by the National Health and Medical Research Council
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