International Neonatal Immunotherapy Study (INIS): a randomised trial of intravenous immunoglobulin for neonatal sepsis

有令人乐观的证据表明，使用血液中自然存在的产品静脉注射免疫球蛋白（IVIG）治疗婴儿严重感染可将死亡率降低40%，并减少幸存者的脑损伤。这将减轻残疾给家庭、保健服务和社会带来的社会、情感和经济负担。仅在经济方面，照顾一个严重残疾的儿童每年要额外花费5万美元。然而，在将IVIG作为新生儿严重感染的常规治疗之前，还需要更多的证据。国际新生儿免疫治疗研究（INIS）是一项随机试验，在全球150个中心的5000名新生儿中研究IVIG的潜在益处。澳大利亚和新西兰有26个中心，预计1500名婴儿的贡献将对研究的成功至关重要。INIS得到了联邦政府和澳大利亚红十字会血液服务中心的支持，后者将监督IVIG的供应和分配，以及NHMRC临床试验中心，后者将协调这项研究。婴儿将在2岁时进行详细的专家评估，并完成家长问卷调查，以评估他们的发展。将进行经济评估，以估计澳大利亚保健服务部门和与试管婴儿治疗有关的家庭的长期节省。将在澳大利亚使用的IVIG产品是CSL生产的Intragam P，该公司拥有无与伦比的安全记录。CSL自1989年以来一直在进行免疫球蛋白注射，从未报告过艾滋病毒或肝炎病毒的传播。CSL估计，通过IVIG传播这些病毒的风险低于千万分之一。INIS将提供有关IVIG的可靠证据，这是一种已知风险最小的治疗方法，可能使数千名澳大利亚儿童和全世界数百万儿童受益。

There is promising evidence that treatment of serious infection in babies with a product naturally occuring in blood, intravenous immunoglobulin (IVIG), may reduce deaths by 40% and reduce brain damage in survivors. This would reduce the social, emotional and financial burden of disability on families, health services and society. In financial terms alone, caring for a severely disabled child costs an extra $50,000 per year. However, more evidence is needed before IVIG can be introduced as routine treatment for serious infection in the newborn. The International Neonatal Immunotherapy Study (INIS) is a randomised trial to study the potential benefits of IVIG in 5,000 newborn babies in 150 centres world wide. 26 centres are in Australia and New Zealand, whose expected contribution of 1,500 babies will be vital to the success of the study. INIS is supported by the Commonwealth Government and Australian Red Cross Blood Service, who will oversee the supply and distribution of IVIG, and the NHMRC Clinical Trials Centre, who will coordinate the study. Infants will have a detailed specialist assessment at 2 years of age and a parent questionnaire will be completed, to assess their development. An economic evaluation will be performed to estimate the long-term savings to Australian Health Services and families associated with the IVIG therapy. The IVIG product to be used in Australia is Intragam P, manufactured by CSL, who have an unrivalled safety record. CSL has been making IVIG since 1989 and no transmission of HIV or hepatitis viruses has ever been reported. CSL estimate the risk of transmission of these viruses by IVIG is under 1 in 10 million treatments. INIS will provide reliable evidence about IVIG, a treatment with minimum known risk that may benefit thousands of Australian children and millions more worldwide.