INIS – the Australian Experience

Oxford - 12-13 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

*John Hunter Hospital

*Westmead Hospital

*Liverpool Hospital

*Royal Hospital For Women

*Royal North Shore

*RPA Women and Babies

*The Children’s Westmead

*Nepean

ANZ and UK Recruitment

Australia and New Zealand Recruitment

0

5

10

15

20

25

30

35

40

F M A M J J A S O N D J F M A M J J A S O N D J F M A M J J A S O N D J F M A M J J A

Year/Month

Num

ber o

f bab

ies

recr

uite

d/m

onth

NZ Aus

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

0.0%

20.0%

40.0%

60.0%

80.0%

100.0%

120.0%

102 201 202 203 205 213 222 255 279 331 341 343 344 401 504 515 701 901 902 903 911 915 922 927

Site

Eligibility Log

Actual recruitment /Eligible babies

0.00%

20.00%

40.00%

60.00%

80.00%

100.00%

102 201 202 203 205 213 222 255 279 331 341 343 344 401 504 515 701 901 902 903 911 915 922 927

Site

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…

0.0%

25.0%

50.0%

1 2 3 4 Diff icult torecruit

Not eligible Unknow n

Reason for not participating

% o

f p

eo

ple

sa

yin

g n

o in

ca

teg

ory

% 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.

0.0

20.0

40.0

60.0

80.0

100.0

102 201 202 203 205 213 222 255 279 331 341 343 344 401 504 515 701 901 902 903 911 915 922 927

Site

% f

am

ilie

s t

ha

t s

aid

ye

s w

he

n

ap

pro

ac

he

d.

Baby Birthweight

0

100

200

300

400

300-400

401-500

501-600

601-700

701-800

801-900

901-1000

1001-1250

1251-1500

1501-2000

2001-3000

3001-4000

4001-5000

Birthweight (gm)

No

. b

abie

s el

igib

le

Baby Gestational Age

0

50

100

150

200

250

20 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43

Gestational Age (Wks)

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

supportAnnual Births in UK vs. ANZ

  UK ANZ

Annual Births ~ 700,000 ~310,000

Number of NICUs 220 28

Total births/ NICU ~3,200 11,000

ANZ Recruits

• We encourage a wide spectrum of illness severity babies to be recruited

• Relatively lower overall mortality rate

  ANZ Whole Trial

Number of babies 870 1596

Mortality rate (%) 12.8 14.6

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!