International Neonatal Immunotherapy Study

ISRCTN	ISRCTN94984750
DOI	https://doi.org/10.1186/ISRCTN94984750
Secondary identifying numbers	MRC ref: G9900825; ACTRN12606000273583

Submission date: 25/10/2000
Registration date: 25/10/2000
Last edited: 23/02/2021

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Infections and Infestations

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Study website

Contact information

Dr Peter Brocklehurst
Scientific

National Perinatal Epidemiology Unit
Institute of Health Sciences
Old Road
Oxford
OX3 7LF
United Kingdom

Study information

Study design	Double-blind placebo-controlled randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Patient information can be found at: https://www.npeu.ox.ac.uk/inis/leaflets
Scientific title	International Neonatal Immunotherapy Study
Study acronym	INIS
Study objectives	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(s)	Australia: Westmead Hospital Ethics Committee, 17/12/2001, ref: 2001/7/4.22 (1080) All other centres obtained approval before participating in this trial.
Health condition(s) or problem(s) studied	Obstetrics and Gynaecology
Intervention	Intravenous infusion of IVIG (500 mg [10 ml]/kg) or matching placebo, repeated after 48 h.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	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 study start date	01/06/2001
Completion date	31/12/2008

Eligibility

Participant type(s)	Patient
Age group	Neonate
Sex	Both
Target number of participants	5,000
Key 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
Key exclusion criteria	IVIG already given or thought to be needed or contraindicated.
Date of first enrolment	01/06/2001
Date of final enrolment	31/12/2008

Locations

Countries of recruitment

Argentina
Australia
Belgium
Denmark
England
Greece
Ireland
New Zealand
Serbia
United Kingdom

Study participating centre

National Perinatal Epidemiology Unit

Oxford
OX3 7LF
United Kingdom

Sponsor information

University of Oxford (UK)
University/education

University Offices
Wellington Square
Oxford
OX1 2JD
England
United Kingdom

Phone	+44 (0)1865 270000
Email	research.services@admin.ox.ac.uk
Website	http://www.ox.ac.uk
"ROR"	https://ror.org/052gg0110

Funders

Funder type

Research council

Medical Research Council (UK)
Government organisation / National government

Alternative name(s): Medical Research Council (United Kingdom), UK Medical Research Council, MRC
Location: United Kingdom

National Health and Medical Research Council (NHMRC) (Australia)
Government organisation / National government

Alternative name(s): NHMRC
Location: Australia

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article	protocol	08/12/2008		Yes	No
Results article	results	29/09/2011		Yes	No

Editorial Notes

23/02/2021: Internal review.