Neonates with severe hyperbilirubinaemia Neonatal Diseases Neonates with severe hyperbilirubinaemia
Conditions
Interventions
The intervention is 20% Albumin which is compared to normal maintenance fluid. The study participants are randomised into two arms namely those who receive the study drug(20% neonatal albumin in the f
Sponsors
Kenya Medical Research Institute (KEMRI) (Kenya)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age 0 to 30 days 2. Bilirubin levels greater than 250 µmols/l 3. Neonates whose guardians consent to the study
Exclusion criteria
Exclusion criteria: 1. Neonates with gross congenital abnormalities not compatible with life, such as neural tube defects 2. Clinical evidence of kernicterus 3. Severely ill neonates likely to die e.g., neonates with severe respiratory distress 4. Suspected obstructive jaundice e.g., biliary atresia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Number of exchange blood transfusions 2. Mortality Children will be discharged from the study after the 36 months of age. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Neurological sequelae on discharge and at 12, 24 & 36 months of age. Children will be discharged from the study after the 36 months of age. | — |
Countries
Kenya
Outcome results
None listed