INIS Collaboratorss Meeting PSANZ 4 April 2006

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INIS Collaboratorss Meeting PSANZ 4 April 2006
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• Total        117 centresTotal     2272 babies
• Well done, thank you for your hard work!
• Because the event rate is higher than originally
  planned, the UK MRC have revised the target
  sample size from 5,000 to 4,000 to preserve power
  to show a 14 Relative Risk Reduction.
• MRC have also awarded an extra years funding

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INIS TRIAL UPDATE MEETING AGENDA

• Websites google inis ctc
• Current recruitment and follow up
• MRC funding extension till June 2007
• Revised sample size 4,000
• Recommencement of European/ Argentinean sites
• Neonatal sepsis, inflammation and
  anti-inflammatory therapies
• Video consent study
• Any Other Business

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inis website

• Google
• inis ctc

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(No Transcript)
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Australian recruitment 2006
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New Zealand recruitment 2006
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• TOTAL RECRUITMENT ANZ
• 1071 in 24 centres

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Total centres and babies worldwide

• ANZ             24 Total babies 1071
• UK               64 Total babies 1120
• Denmark       3Belgium         1Eire        
        2Serbia           1 Greece          
  1Argentina     21 Total babies 81Total
  centres 117 Total babies 2272

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• Recruitment was temporarily suspended in UK,
  Europe and Argentina in Jan 2006
• Until compliance with new documentation
  requirements for good manufacturing practice
• Not because of any safety issue with the Scottish
  IVIG product

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• Recruitment recommenced 24 March in UK, Europe
  and Argentina
• Argentina have 21 centres
• Estimated contribution of 50 babies per month

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1 year follow up

• Important to maintain contact with families at 1
  year to maximize the 2 year follow up rate
• 490 babies have reached 1 year corrected for
  gestation
• 452 babies have complete data
• 37 have data pending
• 1 is presumed lost to follow up

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2 year Follow up

• ANZ sites
• 205 babies surviving babies have reached 2 years
  corrected for gestation
• Currently 180 (88) have complete data
• 24 have appointments pending
• 1 is lost (? Moved to Samoa)
• Expected rate of 2 year follow up is 99

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MRC extension funding application

• UK MRC has funded an extra years funding for UK/
  European and Australian sites.
• This will extend recruitment in Australia until
  mid or late 2007

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Revised sample size
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Neonatal sepsis, inflammation and
anti-inflammatory therapies

• Neonatal inflammation is an important determinant
  of white matter damage
• IVIG has multiple immuno-modulatory properties
• IVIG is an important candidate as an
  anti-inflammatory therapy in neonatal sepsis

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Reviews of the evidence that perinatal
inflammation predisposes to neonatal brain damage

• Inflammation and preterm birth
• John Newnham
• Inflammation and the developing human brain
• Don Peebles
• Antenatal inflammation consequences for neonatal
  immunology
• Alan Jobe

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• Can a 500 g baby mount an over-inflammatory
  response?

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YES, plasma TNF level gt 1000 pg/ml
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• INIS is addressing a major research question
• Does IVIG reduce mortality and morbidity in
  infants with suspected or proven neonatal
  infection?

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A CONSENT DVD DESIGNED TO IMPROVE CONSENT UPTAKE
TO RANDOMISED CONTROLLED TRIALS IN
NEONATOLOGYA PILOT STUDY IN THE INIS NETWORK

• Priya Duggal-Beri, Phyllis Butow, Wendy Hague ,
  Val Gebski, Lorraine ORegan, William
  Tarnow-Mordi on behalf of the
• International Neonatal Immunotherapy Study (INIS)
  Collaborative Group.

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Barriers to participation in randomised
controlled trials a systematic review.Ross et
al 1999

• Clinician barriers included
• time constraints
• lack of staff and training
• worry about the impact on the doctor-patient
  relationship
• concern for patients
• loss of professional autonomy
• difficulty with the consent procedure
• lack of rewards and recognition
• insufficiently interesting question.

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• Patient barriers included
• additional demands of the trial
• patient preferences
• worry caused by uncertainty
• concerns about information and consent.

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• There is no evidence on the impact of Digital
  Video Decoders (DVDs) or videos on knowledge or
  confidence of staff in obtaining consent, and on
  uptake of consent by parents.
• We explored the effectiveness of a DVD/ video and
  accompanying booklet in 24 INIS sites in
• describing consent delivery methods
• improving knowledge about the INIS trial.

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VINIS Video/ DVD Booklet site intervention
study

• A pilot RCT in 24 ANZ INIS sites to explore
• whether a video and booklet for staff who seek
  consent can improve their knowledge and
  confidence
• its potential effect on recruitment rate.
• 1645 Wednesday 5th April
• Level 2 Meeting Room 11

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Data Collection issues

• Excellent rate of completion and accuracy of CRFs
• Consent forms
• Please ensure that all signatures by parents and
  investigators and witnesses are complete
• HIC consent forms
• Please remember to ask new and old parents to
  complete this consent form (for economic
  analysis)
• Days of respiratory support after INIS
  intervention
• Please include all days the baby received any
  respiratory support in your hospital