Long-term neurodevelopmental outcomes of infants following neonatal sepsis: a multicentre prospective cohort study
Assessment of neurodevelopmental impairment in infants with neonatal sepsis
The NeoSep LTFU1 study is a nested prospective cohort study that aims to recruit neonates from four sites in sub-Saharan Africa participating in the NeoSep1 randomised controlled trial (https://www.isrctn.com/ISRCTN48721236) and/or the SNIP-AFRICA neonatal infection surveillance study. This study will longitudinally assess the development of neonates treated for sepsis in the neonatal period using the GSED tool. The GSED short form (SF) will be adopted for NeoSep LTFU1. GSED assessments will be completed at days 28, 90, 180 and 360. The secondary outcome will be neurodevelopmental impairment at one year of age (DAZ score < 1.5) as a binary outcome.
1. Neonates enrolled to the NeoSep1 trial (https://www.isrctn.com/ISRCTN48721236) and/or SNIP-AFRICA surveillance study at a participating NeoSep LTFU1 site. All babies included in the study will have experienced at least one episode of clinical or culture positive sepsis as per the inclusion criteria of the parent studies. 2. Parent(s)/guardian(s) willing and able to provide consent for the study and provide follow-up information via telephone and/or in-person.
1. Neonates with co-morbidities and/or congenital abnormalities that are known or are likely to lead to severe NDI. The decision to exclude neonates will be at the discretion of the responsible clinician. Conditions that may lead to severe NDI include but are not limited to: 1.1. Severe hypoxic ischaemic encephalopathy 1.2. Chromosomal abnormalities e.g. Edwards syndrome (trisomy 18) or Patau syndrome (trisomy 13) 1.3. Severe microcephaly 2. Neonates known to have received a complete course of intravenous (IV) antibiotics for neonatal infection at another hospital prior to transfer to participating centres