Current status:
- Recruiting at 11/11 PREDICT sites, 326 patients enrolled to date.
- US recruiting at 20 sites, with 2900 patients recruited so far. Canada are recruiting at 10 site, with 137 enrolments so far.
- Townsville University Hospital will commence recruitment for PROMPT Bolus in June 2023, awaiting local governance approval.
- International DSMB will meet for the second time- June 2023
- Protocol amendment lowering the age of inclusion has been implemented- current inclusion criteria is aged 2 months to less than 18 years of age.
- Quarterly newsletters are sent to all sites, with data queries and study compliance
- Waiver of consent to randomised followed by written consent to continue remains in place will nil issues.
- Yearly site audits for 2023 will commence in May 2023- we look forward to meeting with all of the site staff.