 Analyses The following characteristics will be compared between babies with proven and suspected sepsis in tabular form: baseline characteristics, clinical characteristics at presentation with sepsis, neonatal outcome at discharge; outcome at two years. Primary and secondary outcomes at two years will be compared between the two groups in univariable analyses using Chi square test. Multivariable adjustment for potential confounders around birth and at presentation with sepsis including country and INIS study drug will be performed using separate logistic regression models for each outcome. The logistic regression models will be considered the primary analyses. Separate models will be constructed for major disability and for any disability majornon-major. 