Condition category
Infections and Infestations
Date applied
25/10/2000
Date assigned
25/10/2000
Last edited
14/07/2014
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.npeu.ox.ac.uk/inis

Contact information

Type

Scientific

Primary contact

Dr Peter Brocklehurst

ORCID ID

Contact details

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

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 measures

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

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

http://www.ox.ac.uk

Funders

Funder type

Research council

Funder name

Medical Research Council (UK)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

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

Results - basic reporting

Publication summary

2008 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/19063731
2011 results in: http://www.ncbi.nlm.nih.gov/pubmed/21962214

Publication citations

  1. 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.

  2. 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.

Additional files

Editorial Notes