The effect of BCG vaccination on serum iron status in neonates Neonatal Diseases
Conditions
Interventions
BCG-Danish 0.05ml Intra-dermally. Subjects randomised to receive BCG vaccination on the first day of life (<24 hours of age) or delayed to following their second blood test (24-96 hours of age). Follo
Sponsors
Medical Research Council (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Neonates seen within the first 24 hours of age 2. Neonates resident in West Kiang, The Gambia and enrolled in the West Kiang Demographic Surveillance System
Exclusion criteria
Exclusion criteria: 1. Neonates with birth weight less than 2000g 2. Neonates with severe birth asphyxia 3. Neonates with major congenital malformations 4. Neonates born to mothers with known HIV or active tuberculosis 5. Neonates born into families with a known active case of tuberculosis in the same compound 6. Neonates currently enrolled in another research study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Plasma transferrin saturation 2. Plasma hepcidin level: ELISA - Bachem-25 3. Plasma IL-6 level: ELISA All outcomes will be measured at baseline (cord blood), <24 hours of age and at either 24 (+/- 4 hours) or 72 hours (+/- 4 hours) from the time of the first venous blood sample. The timing of the second sample (24 or 72 hours) is randomly assigned. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Serum iron 2. Serum Unbound Iron Binding Capacity 3. Ferritin 4. Transferrin 5. Red cell parameters (haemoglobin, mean corpuscular volume, mean corpuscular haemoglobin, mean corpuscle haemoglobin concentration, haematocrit, red cell distribution width, red blood cell count) measured by Automated Analyser (Medonic) Iron parameters are measured by Automated Cobas Analyser (Roche). | — |
Countries
Gambia
Outcome results
None listed