About PAEAN


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 procedures?

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:

•           Epo treatment

OR

•           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 treatment. 

 

How many babies are taking part? 

Current recruitment total: 26 (as of December 2016) 

Recruitment target: 300 

 

Coordination, sponsorship and funding

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 (NHMRC). 

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