PERINATAL TRIALS REPORT

PTO373

INIS Trial

International Neonatal Immunotherapy Study

Plain language summary:

This trial will test if intravenous immunoglobulin (IVIG) reduces death and disability in up to 5000 babies with suspected serious infection in the UK, Australia and New Zealand. Newborn babies are deficient in immunoglobulins (physiological deficiency), especially if they are premature. Babies with severe infection after birth carry a high risk of death or life-long disability, even with appropriate antibiotics. IVIG is concentrated from plasma carefully screened blood donors and is one of the safest blood products available. Earlier trials suggest IVIG may reduce death rates in newborn infants, but did not report disability rates in survivors.

Trial Status:                                   Open to accrual

Date trial opened to accrual:            October 2001

Expected accrual period:                 June 2006

Trial Objective:

In infants receiving antibiotics for clinical sepsis, does the addition of non-specific, polyclonal intravenous immunoglobulin IgG (IVIG) therapy reduce mortality and major morbidity compared with antbiotics alone?

Type of administration:        Multi-centre International

For further details:              http://www.npeu.ox.ac.uk/inis/

Prinicipal Investigator:                       Peter Brocklehurst

                                                       Ph +44 1865 227 000

                                                       Email: peter.brocklehurst@perinat.ox.ac.uk

Contact Person:                                Priya Duggal-Beri

                                                        Ph +612 9562 5335

                                                        Email: inis@ctc.usyd.edu.au 

© IMPACT/PSANZ 2001