NPEU

INIS

Total number of babies recruited: 3493

INIS has now finished recruiting. The last baby to follow-up was due to be assessed on the 16th November 2009. Follow-up phase will continue until all the data has been collected.

Number of babies aged two (corrected) eligible for follow-up by 11 December 2009 for UK, Europe and Argentina: 1652

One or both Follow-up questionnaires received (Health Status Questionnaire and/or Parent Questionnaire): 1565 (95%)

General Summary

The International Neonatal Immunotherapy Study is an international multi-centre randomised controlled trial which aims to evaluate the use of non-specific intravenous immunoglobulin (IVIG) in addition to antibiotics in babies with suspected or proven sepsis.

A meta-analysis of small trials has suggested that IVIG may reduce the rate of neonatal death, and this trial is designed to confirm or refute the hypothesis that IVIG reduces the rate of mortality and major morbidity. The study is designed to be as simple as possible so that staff in participating units will be able to recruit babies to the study without difficulty and without a large investment of time.

Eligibility

Babies were eligible to be recruited to the INIS study if:

  • They were receiving antibiotics
    AND
  • had proven or suspected serious infection
    It did not have to be life threatening AND
  • They had at least one of following:
    • birthweight less than 1500g
    • respiratory support via an endotracheal tube
    • evidence of infection in blood culture, CSF or usually sterile body fluid
    AND
  • There was substantial uncertainty that IVIG is indicated

Some more information about INIS

  • The INIS study recruited 3493 babies between October 2001 and September 2007 across 9 different countries.
  • The INIS follow-up phase will continue until all children recruited to INIS have turned two years of age, attended their follow-up, and we have received follow-up questionnaires from parents and Paediatricians.

Results

We anticipate the INIS follow-up phase to be completed late 2009. Therefore the results of the study will be available early 2010.

INIS follow-up phase

The primary outcome is death or major disability at 2 years of age (corrected). Therefore all children will be followed up at 2 years (corrected for gestational age) in order to have data for our primary outcome of the study.

The follow-up procedure

Paediatric Assessment

Health Status Questionnaire data completed by Paediatricians will allow us to assess each child's health at 2 years (age corrected).

Download a copy of the Health Status Questionnaire.

Parent Questionnaire

Follow-up data is also collected from the parents of each child recruited, in the form of a Parent Questionnaire.

Download a copy of the Parent Questionnaire.

A Note for Parents

Please be aware that this website is NOT aimed at the parents of participating babies. If you require support, please use the services provided by BLISS.(Visit Bliss website).

INIS Co-ordinating Team

Contact Details

  • INIS Co-ordinating Centre
  • National Perinatal Epidemiology Unit (NPEU)
    University of Oxford
    Old Road Campus    OxfordOX3 7LF
  • 01865 289741
  • 01865 289740

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