International neonatal immunotherapy study

This trial will test if intravenous immunoglobulin (IVIG) reduces death and disability in up to 5000 babies with suspected serious infection in the UK, Europe, Argentina, 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. Participants, Trialists at the coordinating centre, and clinical professionals involved in the care of the child are blinded to the study treatment. Only the pharmacist and lead statistician are aware of the treatment allocation.