Inis collaborators s meeting psanz 4 april 2006
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INIS Collaborators’s Meeting PSANZ 4 April 2006 PowerPoint PPT Presentation


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INIS Collaborators’s Meeting PSANZ 4 April 2006. Total        117 centres Total     2272 babies Well done, thank you for your hard work!

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INIS Collaborators’s Meeting PSANZ 4 April 2006

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Inis collaborators s meeting psanz 4 april 2006

INIS Collaborators’s Meeting PSANZ 4 April 2006


Inis collaborators s meeting psanz 4 april 2006

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 year’s funding


Inis trial update meeting agenda

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


  • Inis website

    inis website

    [Google]

    inis ctc


    Australian recruitment 2006

    Australian recruitment 2006


    New zealand recruitment 2006

    New Zealand recruitment 2006


    Inis collaborators s meeting psanz 4 april 2006

    TOTAL RECRUITMENT ANZ

    = 1071 in 24 centres


    Total centres and babies worldwide

    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


    Inis collaborators s meeting psanz 4 april 2006

    • 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


    Inis collaborators s meeting psanz 4 april 2006

    • Recruitment recommenced 24 March in UK, Europe and Argentina

    • Argentina have 21 centres

      • Estimated contribution of 50 babies per month


    1 year follow up

    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


    2 year follow up

    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%


    Mrc extension funding application

    MRC extension funding application

    • UK MRC has funded an extra year’s funding for UK/ European and Australian sites.

    • This will extend recruitment in Australia until mid or late 2007


    Revised sample size

    Revised sample size


    Neonatal sepsis inflammation and anti inflammatory therapies

    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


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

    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


    Inis collaborators s meeting psanz 4 april 2006

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


    Inis collaborators s meeting psanz 4 april 2006

    YES, plasma TNF level > 1000 pg/ml


    Inis collaborators s meeting psanz 4 april 2006

    • INIS is addressing a major research question

    • Does IVIG reduce mortality and morbidity in infants with suspected or proven neonatal infection?


    Inis collaborators s meeting psanz 4 april 2006

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

    Priya Duggal-Beri, Phyllis Butow, Wendy Hague , Val Gebski, Lorraine O’Regan, William Tarnow-Mordi; on behalf of the

    International Neonatal Immunotherapy Study (INIS) Collaborative Group.


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

    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.


    Inis collaborators s meeting psanz 4 april 2006

    • Patient barriers included:

      • additional demands of the trial

      • patient preferences

      • worry caused by uncertainty

      • concerns about information and consent.


    Inis collaborators s meeting psanz 4 april 2006

    • 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.


    Vinis video dvd booklet site intervention study

    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


    Data collection issues

    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


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