Costly treatment ‘ineffective for babies’
INIS: the importance of reliable, high quality research for all age groups
A worldwide study led in Australia by Professor William Tarnow-Mordi
(Director of Neonatal Trials at the CTC and Director of the WINNER
Centre for Newborn Research) and involving CTC researchers has
concluded that a costly and controversial treatment for neonatal
sepsis is ineffective. Neonatal sepsis is a blood infection in
newborn babies and a leading cause of infant death.
The International Neonatal Immunotherapy Study (INIS)
investigated the use of intravenous immune globulin (IVIG) as a
treatment for infection in more than 3000 babies from neonatal
intensive care units across the globe.
The study, published in the New England Journal of
Medicine (http://www.ncbi.nlm.nih.gov/pubmed?term=INIS%20NEJM%202011), concluded
that the rate of death or severe disability in babies with
suspected or proven neonatal sepsis who were given IVIG was the
same-39%-as in those who were given the placebo.
Professor Tarnow-Mordi, said newborns have low levels of
antibodies against infection, known as immune globulins. Earlier
research had suggested that treatment with IVIG, a human blood
product extracted from donated blood, could reduce deaths in babies
with serious infection by half.
Professor Tarnow-Mordi said: 'While some authorities had
recommended routine IVIG in babies with suspected infection, others
have been waiting for the results of INIS. IVIG is not cheap, and
supplies are strictly limited. It requires significant time and
effort to administer, with added risks of fluid overload or of
introducing hospital-acquired infection. This study did not show
the moderate reductions in death or disability which we were
looking for. Reducing the use of IVIG in babies could help free up
this precious resource for other sick patients'.
'Members of the INIS Collaborative Group are to be congratulated
on a major achievement', said Associate Professor John Ziegler,
Chair of NSW Health IVIG Users Group. 'This encourages others to
investigate, with equal rigour, whether IVIG is effective-and cost
effective-in other illnesses where a role for IVIG is suspected but
'The International Neonatal Immunotherapy Study illustrates the
importance of reliable, high-quality research for clinical policy
across all age groups', added Professor Warwick Anderson, Chief
Executive Officer of the National Health and Medical Research
More than 40% of the newborns participating in the trial
were recruited in neonatal units in Australia or New Zealand,
coordinated through the CTC.
Worldwide, the trial was coordinated by the National Perinatal
Epidemiology Unit in the University of Oxford, led by Professor
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The study was funded locally by the National Health and
Medical Research Council, with additional funding from the UK
Medical Research Council and New Zealand Health Research Council.
IVIG in Australia was made available to hospitals by the Australian
Red Cross Blood Service and funded by Australia's state