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 (, 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 not established.'

'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 Council.

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 Peter Brocklehurst.

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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 governments.