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Trials > INIS
International Neonatal Immunotherapy Study (INIS)
| INIS
project manager–trial coordinator: Lucille Sebastian INIS is a major international, double-blind, placebo-controlled randomised trial that will evaluate the effect on mortality and disability of adding polyclonal IVIG to standard antibiotic therapy in 5000 newborn infants with sepsis. Of these, 1500 are being recruited in Australia and New Zealand. Newborn infants, particularly those born early, are deficient in immunoglobulin (IgG) and so are at an increased risk of infection. Each year over 2500 babies in Australia and New Zealand develop serious infection. About 250 die and another 375 survive with lifelong disability. In developed countries, neonatal infection causes over 720 000 deaths or severe disabilities each year. While effective antibiotic treatment is essential, resistance to antibiotics is increasing. Polyclonal IVIG may help to reduce death and brain inflammation resulting from infection. The primary measure of outcome is survival free of major sensorineural disability at two years, corrected for gestational age. As well, some infants in Australia and New Zealand will also undergo a Bayley II Scales assessment at 2 years of age, which is a gold standard test for evaluating sensorineural disability and developmental status (that is, how they talk, walk, think, see and hear). The Commonwealth Government has guaranteed the supply of IVIG (Intragam P) for the trial in Australia. The CTC is the coordinating centre for the study in Australia and New Zealand. |
Go
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Australian and New Zealand INIS web site |
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