Neonatal infections are estimated to account for a quarter of the 2·8 million annual neonatal deaths, as well as approximately 3% of all DALYs. Despite this burden, data are limited on incidence, aetiology and outcomes, particularly regarding impairment. We aimed to develop guidelines for improved scientific reporting of observational and interventional neonatal infection studies, to increase comparability and to strengthen research in this area. This statement, Strengthening the Reporting of Observational Studies in Epidemiology for Newborn Infection (STROBE-NI) is an extension of the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) checklist. STROBE-NI was developed following systematic reviews of published literature (1996)(1997)(1998)(1999)(2000)(2001)(2002)(2003)(2004)(2005)(2006)(2007)(2008)(2009)(2010)(2011)(2012)(2013)(2014)(2015), compilation of over 130 potential reporting recommendations, and circulation of a survey to relevant professionals worldwide, eliciting responses from 147 professionals from 37 countries. An international consensus meeting of 18 participants (with expertise in infectious diseases, neonatology, microbiology, epidemiology and statistics) identified priority recommendations for reporting, additional to the STROBE statement. Implementation of these STROBE-NI recommendations, and linked checklist, aims to improve scientific reporting of neonatal infection studies, increasing data utility and allowing meta-analyses and pathogen-specific burden estimates to inform global policy and new interventions, including maternal vaccines.