Assessment of neurodevelopmental impairment in infants with neonatal sepsis Infections and Infestations
Conditions
Interventions
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.is
Sponsors
City St George's, University of London
Eligibility
Sex/Gender
All
Age
1 Days to 1 Months
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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
Countries
Ghana, South Africa, Tanzania, Uganda
Contacts
Public ContactCharlotte Sanders
Outcome results
None listed