baby feet 1 free 5991262472440.jpgWhat is PROTECT?

What are the study procedures? 

What are we trying to find out?

How many babies are taking part? 

Coordination, Sponsorship and Funding


What is PROTECT?

Preterm infants born less than 29 weeks gestation are at an increased risk, approximately 1 in 3, of developing blood infection (sepsis) or necrotising enterocolitis (NEC), inflammation of the bowel. Both sepsis and NEC initiate harmful systemic inflammation which can lead to brain injury and subsequently an increased risk of disability. Currently sepsis and NEC are treated with antibiotics, supportive care and surgery in some NEC cases, but there is no treatment for the harmful inflammation.  Pentoxifylline is a safe, non-steroidal drug that can suppress inflammation and used along with standard treatment may improve survival and reduce the risk of disability in babies with sepsis or NEC. Disability of babies enrolled in the trial will be assessed at two years of age.

PROTECT is a multicentre double blind, placebo controlled, randomised trial. We anticipate sites in Australia, New Zealand, Singapore, Taiwan and Canada.

What are we trying to find out?

Treatment with Pentoxifylline may improve survival without disability. We will assess disability at two years of age during a routine follow-up appointment as part of your baby's standard care and treatment.


How many babies are taking part? 

Current recruitment total:  123 (as of May 2018)

Recruitment target:        1,800 with suspected sepsis or NEC, anticipating 900 babies will have confirmed or clinical sepsis or proven NEC.

What are the study procedures?

Current treatment for babies with sepsis or NEC is treatment with antibiotics, supportive care and surgery in some NEC cases. However, the current treatment does not address reducing harmful inflammation associated with a higher risk of long-term disability. Therefore, when babies are enrolled to the trial in addition to standard treatment for sepsis or NEC they will be randomly selected to receive either:

  • Pentoxifylline treatment


  • Placebo treatment. The placebo treatment is saline (dilute salt water).


Coordination, Sponsorship and Funding 

PROTECT is a collaboration between the University of Western Australia and the NHMRC Clinical Trials Centre. This trial is coordinated by the Clinical Trials Centre and is sponsored by the University of Sydney. Funding is provided by the National and Medical Research Council (NHMRC).


ANZCTR registration number: ACTRN12616000405415

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Participating sites



John Hunter Hospital, NSW

Royal Hospital for Women, NSW

Royal Prince Alfred Hospital, NSW

Nepean Hospital, NSW

Royal North Shore Hospital, NSW

Liverpool Hospital, NSW

King Edward Memorial Hospital, WA

Canberra Centenary Hospital for Women, ACT

Flinders Medical Centre, SA

Royal Children's Hospital, VIC

Royal Women's Hospital, VIC

Mater Women's Hospital, QLD


New Zealand

Wellington Hospital


Paed Nurse