The PROTECT Study
Pentoxifylline to PROTECT the preterm brain
If you are interested in participating at King Edward Memorial Hospital,
please contact ProtectKEMH@health.wa.gov.au
Very preterm babies (less than 29 weeks gestational age) are prone to infections in their blood (sepsis) and in their gut (necrotising enterocolitis; NEC). 1 in 3 preterm infants will have an infection at some point during their stay in the hospital. These infections can cause inflammation to circulate around the baby’s body, and we know this inflammation can also cause some brain injury. This increases the risk of developmental delays and disability by the time these children have reached school age.
Currently antibiotics and supportive care are used to treat infection.
But there is no medicine given to decrease inflammation
when preterm babies have an infection.
The PROTECT study is investigating whether the medicine, Pentoxifylline,
can help preterm babies with infection to survive without long-term disability.
Pentoxifylline is a safe, non-steroidal medicine, which has been used for decades in adults and safely in over 700 babies. A recent study found Pentoxifylline was well tolerated and safe to use, even in the smallest and most unwell preterm infants.
If you consent to have your baby take part in the trial at King Edward Memorial Hospital, your baby will receive the routine standard care, as well as the PROTECT study treatment during every episode of infection. The PROTECT study treatment will be either Pentoxifylline or placebo (diluted salt water).
- The PROTECT study treatment will continue for 2 or 6 days depending on the blood test results.
- Before and after the PROTECT study treatment, a few drops of blood may be collected.
- When your baby reaches 40 weeks corrected age, they may have an MRI to analyse their brain.
- We will keep in touch with you every 6 months about how you and your baby are going.
- Once your baby reaches 2 years of age:
- We will ask you to fill out some questionnaires and
- Your baby will complete a development assessment with the psychologist.
We aim to enrol 1800 preterm babies (born between 23 and 29 weeks) around the world into this study, with King Edward Memorial Hospital as the leading site.
By taking part in this study, you will be contribute to helping improve medical knowledge and treatment of preterm babies in the future.
The PROTECT study is a collaboration between the University of Western Australia and the NHMRC Clinical Trials Centre. The National Health and Medical Research Council (NHMRC) have provided funding for the PROTECT study.