Background and eligibility


Premi VentilatedBackground

Who is eligible?

Who may not be eligible?

Follow-up

 

Background

PROTECT trial will determine whether the drug Pentoxifylline improves survival without disability in babies with sepsis or NEC. Additional clinical outcomes, such as length of hospital stay, will also be evaluated.

Pentoxifylline is an investigational treatment, meaning it is not an approved treatment for sepsis or NEC in preterm babies in Australia or elsewhere.

 

Who is eligible?

Preterm infants born between 23 and 29 weeks gestation with suspected sepsis or NEC.

Written informed consent from parent(s) or guardian.

Who may not be eligible?

Any condition, such as major congenital malformation(s) or chromosomal abnormalities, considered to be likely to be incompatible with disability-free survival.

Follow-up

This study will keep up to date on each baby's progress through routine follow-up appointments as part of their standard care and treatment.  At two years of age your child will be assessed as part of their routine follow-up, the assessment will include:

  • A Short Health Status questionnaire

  • Ages and Stages Questionnaire

  • Bayleys Scales of Infant Development III

Study personnel will keep in touch with families via phone calls, email and post to send updates, birthday cards and maintain contact.

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