INIS – the Australian Experience Oxford September 2005 Priya Duggal-Beri

The ANZ Team

The ANZ Way Australia (680) – 17 active centres NZ (172) – 7 active centres

Sites in ANZ *Monash Medical Centre *Royal Children’s Hospital *Mercy Hospital for Women *Royal Women’s Melbourne *Royal Hobart Hospital *Royal Women’s Brisbane *Women’s and Children’s *Flinders Medical Centre *Canberra Hospital *National Women’s *Middlemore Hospital *Christchurch Women’s Hospital *Wellington Women’s Hospital * Dunedin Hospital *Waikato Hospital *Palmerston North *Joh n Hun ter Hos pital *Westmead Hospital *Liverpool Hospital *Royal Hospital For Women *Royal North Shore *RPA Women and Babies *The Children’s Westmead *Nepean

ANZ and UK Recruitment

Targets for centres Each site has a set target to recruit to – based on the number of hospital beds Based on estimates at the start of the study Have changed the target for some centres that recruited more or less than the initial set target

Actual/Target Data as at 22/8/05

Eligibility Log

Actual recruitment /Eligible babies Data as at 22/8/05

Reasons why families may not participate 1 - Eligible, not approached for consent, open label IVIG was given - Doctor's decision 2 - Eligible, not approached for consent, open label IVIG was not given - Doctor's decision 3 - Eligible, consent refused by parents, open label IVIG was given 4 - Eligible, consent refused by parents, open label IVIG was not given Of 647 families that said no…

% Families that say yes when approached Families were approached but chose not to participate, did not give a reason for not participating are compared with families who chose to participate.

Baby Birthweight

Baby Gestational Age

INIS in ANZ Recruitment to discharge – similar to UK Follow Up – 1 year follow up Helps sites stay in touch with families Economic evaluation – 2 year follow up Parent and Paediatrician Questionnaires Bayley Scales of Assessment II

ANZ status Completed 2 year follow Up: 97% (completed or booked appts) Completed 1 year follow Up: 96% >1 year old: 413 babies Babies older than 2 years: Staying in touch using Christmas cards/ newsletters. TOTAL RECRUITMENT: 870

Babies/NICUs by region Total births per NICU are greater in ANZ than the UK. Proportionately fewer NICUs in ANZ than in UK. ANZ Nurses have relatively greater funding and support Annual Births in UK vs. ANZ UKANZ Annual Births~ 700,000~310,000 Number of NICUs22028 Total births/ NICU~3,20011,000

ANZ Recruits We encourage a wide spectrum of illness severity babies to be recruited Relatively lower overall mortality rate ANZWhole Trial Number of babies Mortality rate (%)

Parent Newsletters Includes – Parents story – Recipe – Games – INIS news – Stay in touch – “Clinical trials” information

Letters from Parents Letters from parents about the recipes Letters thanking us for staying in touch A mother asked for her second baby to be recruited to INIS, and he/ she was!

Common Link? Enthusiasm of everyone across both hemispheres We applaud our collaborators and nurses, in Europe and ANZ, for the hard work they do. Thank you!