Plain English Summary
Not provided at time of registration
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
MRC ref: G9900825; ACTRN12606000273583
Study information
Scientific title
Acronym
INIS
Study hypothesis
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.
Protocol can be found at: https://www.npeu.ox.ac.uk/downloads/files/inis/INIS-Protocol.pdf
Ethics approval
Australia: Westmead Hospital Ethics Committee, 17/12/2001, ref: 2001/7/4.22 (1080)
All other centres obtained approval before participating in this trial.
Study design
Double-blind placebo-controlled randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Patient information can be found at: https://www.npeu.ox.ac.uk/inis/leaflets
Condition
Obstetrics and Gynaecology
Intervention
Intravenous infusion of IVIG (500 mg [10 ml]/kg) or matching placebo, repeated after 48 h.
Intervention type
Drug
Phase
Not Applicable
Drug names
Intravenous immunoglobulin (IVIG)
Primary outcome measure
Mortality or major disability at 2 years of age (corrected for gestational age at birth).
Secondary outcome measures
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
Overall trial start date
01/06/2001
Overall trial end date
31/12/2008
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
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
Participant type
Patient
Age group
Neonate
Gender
Both
Target number of participants
5,000
Participant exclusion criteria
IVIG already given or thought to be needed or contraindicated.
Recruitment start date
01/06/2001
Recruitment end date
31/12/2008
Locations
Countries of recruitment
Argentina, Australia, Belgium, Denmark, Greece, Ireland, New Zealand, Serbia, United Kingdom
Trial participating centre
National Perinatal Epidemiology Unit
Oxford
OX3 7LF
United Kingdom
Sponsor information
Organisation
University of Oxford (UK)
Sponsor details
University Offices
Wellington Square
Oxford
OX1 2JD
United Kingdom
+44 (0)1865 270000
research.services@admin.ox.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Research council
Funder name
Medical Research Council (UK)
Alternative name(s)
MRC
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
Funder name
National Health and Medical Research Council (NHMRC) (Australia)
Alternative name(s)
NHMRC
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
Australia
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2008 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/19063731
2011 results in: http://www.ncbi.nlm.nih.gov/pubmed/21962214
Publication citations
-
Protocol
The INIS Study. International Neonatal Immunotherapy Study: non-specific intravenous immunoglobulin therapy for suspected or proven neonatal sepsis: an international, placebo controlled, multicentre randomised trial., BMC Pregnancy Childbirth, 2008, 8, 52, doi: 10.1186/1471-2393-8-52.
-
Results
, Brocklehurst P, Farrell B, King A, Juszczak E, Darlow B, Haque K, Salt A, Stenson B, Tarnow-Mordi W, Treatment of neonatal sepsis with intravenous immune globulin., N. Engl. J. Med., 2011, 365, 13, 1201-1211, doi: 10.1056/NEJMoa1100441.