Table 2

Summary of procedures in observational cohort

AssessmentHospitalisationPost discharge*
Baseline†Discharge‡2 weeks4 weeks12 weeks24 weeks48 weeks
Caregiver informed consent to join observational cohortx
Summary checklistx
Locator information§x
Acute admission informationx
Baseline datax
Daily clinical review¶Daily during hospitalisation
Blood collection**xxxxx
HIV testing††x
CD4 count and viral load (HIV-infected children only)xxxx
Full blood count‡‡xxxxx
Anthropometryxxxxxxx
Skinfold thickness§§xxxxxx
Body composition¶¶xxxxxxx
Discharge data collectionx
Daily morbidity diaryDaily during follow-up period by caregivers
Follow-up clinic: history, examination, morbidity and mortality dataxxxxx
  • *Windows will be created around these post-discharge time-points to maximize follow-up for caregivers who miss visits or are unavailable, as follows: 2 weeks (optimal window from 1 week to 2 weeks + 6 days; allowable window up to 2 weeks + 6 days); 4 weeks (optimal window 3-5 weeks, allowable window up to 9 weeks + 6 days); 12 weeks (optimal window 10-14 weeks, allowable window up to 19 weeks + 6 days); 24 weeks (optimal window 20-28 weeks, allowable window up to 43 weeks + 6 days); 48 weeks (optimal window 44-52 weeks, allowable window up to 71 weeks + 6 days). †Children will be enrolled as soon as possible after hospitalisation and will undergo baseline investigations as soon as possible after enrolment. This is to provide a window of opportunity to time collection of research specimens with clinical specimens, and to ensure that the child is clinically stable before undertaking research investigations.

  • ‡The discharge procedures will be undertaken on the day of discharge or as close as possible to that date.

  • §Locator information will be updated at subsequent visits if caregivers have moved or changed contact details.

  • ¶A clinical review will be undertaken every day between admission and discharge by the study clinician.

  • **5.4 mL of blood (depending on child weight; amount will not exceed 2 mL/kg total over 2-week period) will be collected by a study nurse into endotoxin-free EDTA tubes. Samples will be used to store whole blood, Peripheral Blood Mononuclear Cells (PBMC) and plasma for subsequent measurement of C reactive protein and albumin. Where blood sample volumes allow (≥2 mL sample), bacterial binding assays and whole blood stimulations will be conducted and culture supernatants and cells stored for subsequent assessment of immune cell function at each time point. Study blood samples will not be collected from children with known haemoglobin <60g/L.

  • ††HIV testing is conducted as part of routine clinical practice, but if it has not been undertaken, the study sample will be used to test for HIV, as stated in the informed consent form, since HIV status is required to allocate children to study groups.

  • ‡‡Full blood count results will be transcribed from clinical records; if not done by clinical teams, the EDTA sample will be used to measure Full Blood Count (FBC) in clinical laboratories at each site.

  • §§Skinfold thickness (triceps, subscapular, supra-iliac) and mid-thigh circumference will be measured using Holtain callipers or tape measure.

  • ¶¶Body composition will be assessed by bioimpedance vector analysis.