International Neonatal Immunotherapy Study INIS

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International Neonatal Immunotherapy Study (INIS)
Australian and New Zealand INIS COLLABORATORS
MEETING 13/14 MARCH 2004
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STUDY PROGRESS
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Study progress Recruitment

• Worldwide 880 infants recruited by 11 March 04
• UK
• 530 infants (54 UK centres on board)
• 0.5 infants per centre per month (target is 1
  babies per centre per month on average)
• Australia and New Zealand
• 350 infants
• 1.7 infants per centre per month (target is 2
  babies per centre per month on average)

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Study progressParticipating centres

• NSW ACT
• Canberra
• John Hunter
• Liverpool
• Nepean
• Royal Hosp Women
• Royal North Shore
• RPA Women and Babies
• Sydney Children's
• Westmead
• Westmead Childrens
• SA
• Flinders Medical Centre
• Womens Childrens
• QLD
• Royal Women's

• VIC
• Mercy Hospital for Women
• Monash Medical Centre
• Royal Childrens
• Royal Women's
• TAS
• Royal Hobart
• NZ
• Christchurch Womens
• Dunedin
• Middlemore
• National Womens
• Palmerston North
• Waikato
• Wellington Womens

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Funding support

• Funding
• NHMRC
• UK Medical Research Council
• New Zealand Health Research Council
• Financial Markets Foundation for Children
• Telstra Foundation
• Ian Potter travel grant
• Sydney University
• INIS has the additional support of
• Australian Red Cross Blood Service New Zealand
  Blood Service (who distribute the IVIG)
• the Commonwealth (who have given us a free and
  reserved supply of IVIG for the study in
  Australia)
• CSL (who make Intragam P)

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GA distribution of eligible babies
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Recruitment UK and Aust
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Monthly recruitment UK and Aust
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ANZ Recruitment actual vs expected
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ANZ Projected Recruitment
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ANZ Projected Recruitment
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INIS individual unit recruitment
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What are our centres recruitment targets?

• Based on
• size of unit
• no. of funded research nurse hours
• In general, the monthly recruitment targets are
• 1-2 babies for small centres
• 2-3 babies for average sized centres
• 3 babies for larger centres

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Individual recruitment targets
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Individual centre recruitment targets
As at 31 Oct03
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Individual centre recruitment targets
As at 11 March 04
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of eligibles approached
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Consent rate () of those approached
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of eligible babies enrolled