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ISRCTN
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ISRCTN94984750
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DOI
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10.1186/ISRCTN94984750
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ClinicalTrials.gov identifier
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EudraCT number
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Public title
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International Neonatal Immunotherapy Study
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Scientific title
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Acronym
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INIS
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Serial number at source
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MRC ref: G9900825; ACTRN12606000273583
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Study hypothesis
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This trial tests the hypothesis that, in infants receiving antibiotics for clinical sepsis, the addition of non-specific, polyclonal intravenous immunoglobulin IgG (IVIG) therapy reduces mortality and major morbidity compared with antibiotics alone.
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Lay summary
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Ethics approval
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Australia: Westmead Hospital Ethics Committee gave approval on the 17th December 2001 (ref: 2001/7/4.22 (1080))
All other centres obtained approval before participating in this trial.
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Study design
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Double-blind placebo-controlled randomised controlled trial
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Countries of recruitment
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Argentina, Australia, New Zealand, United Kingdom, Europe
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Disease/condition/study domain
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Obstetrics and Gynaecology
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Participants - inclusion criteria
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Infants who:
1. Are receiving antibiotics with clinical evidence of definite or highly probable sepsis
2. There is substantial uncertainty that IVIG is indicated
3. Birth weight is less than 1500 g OR already has positive blood or Cerebral Spinal Fluid (CSF) culture OR receiving artificial ventilation
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Participants - exclusion criteria
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IVIG already given or thought to be needed or contraindicated.
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Anticipated start date
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01/06/2001
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Anticipated end date
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31/12/2008
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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5,000
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Interventions
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Intravenous infusion of IVIG (500 mg [10 ml]/kg) or matching placebo, repeated after 48 h.
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Primary outcome measure(s)
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Mortality or major disability at 2 years of age (corrected for gestational age at birth).
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Secondary outcome measure(s)
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1. Short term: mortality, chronic lung disease or major cerebral abnormality before hospital discharge, significant positive culture after trial entry, pneumonia, necrotising enterocolitis, duration of respiratory support
2. Long term: mortality before two years, major disability at 2 years, non-major disability at 2 years.
3. Health service utilisation: length of hospital stay
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Sources of funding
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1. Medical Research Council (UK)
2. National Health and Medical Research Council (NHMRC) (Australia)
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Trial website
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http://www.npeu.ox.ac.uk/inis
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Publications
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2008 protocol in http://www.ncbi.nlm.nih.gov/pubmed/19063731
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Contact name
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Dr
Peter
Brocklehurst
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Address
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National Perinatal Epidemiology Unit
Institute of Health Sciences
Old Road
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City/town
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Oxford
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Zip/Postcode
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OX3 7LF
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Country
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United Kingdom
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Email
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Sponsor
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University of Oxford (UK)
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Address
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University Offices
Wellington Square
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City/town
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Oxford
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Zip/Postcode
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OX1 2JD
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Country
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United Kingdom
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Tel
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+44 (0)1865 270000
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Email
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research.services@admin.ox.ac.uk
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Sponsor website:
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http://www.ox.ac.uk
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Date applied
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25/10/2000
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Last edited
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16/12/2008
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Date ISRCTN assigned
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25/10/2000
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