The use of albumin to prevent exchange blood transfusions and improve outcome in neonates with severe hyperbilirubinaemia

• Register: ISRCTN
• Last refreshed on: 12 February 2013
• Main ID: ISRCTN89732754
• Date of registration: 16/04/2007
• Primary sponsor: Kenya Medical Research Institute (KEMRI) (Kenya)
• Public title: The use of albumin to prevent exchange blood transfusions and improve outcome in neonates with severe hyperbilirubinaemia N/A
• Date of first enrolment: Jun 1 2006
• Target sample size: 62
• Recruitment status: Completed/Not recruiting
• URL: http://isrctn.org/ISRCTN89732754
• Study type: Interventional
• Study design: Randomised controlled trial of 20% albumin versus normal maintence fluids in neonates with severe hyperbilirubinaemia (total plasma bilirubin greater than 250 µmols/l).

Countries of recruitment

Kenya

Contacts

• Name: Michael Mwaniki

Key inclusion & exclusion 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: 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

Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Neonates with severe hyperbilirubinaemia

Intervention(s)

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 first two hours) and those who just get routine internationally accepted management for jaundice from the start. After the first two hours the rest of the clinical management is the same. All the children are managed in the ward at the discretion of clinically qualified staff till discharge, thus the inpatient period will vary according to the severity of jaundice and any other co-morbidity.

At discharge general and neurological assessment is done by discharging clinicians for each child and then the discharge Event Related Potentials (ERPs) are performed. After discharge the children return to routine health care system. In case of any severe illness requiring hospitalisation the study team is informed.

Follow up assessments are planned at 12, 24, 36 months of age. These assessments consist of a general exam with anthropometric measurement and neurodevelopmental exam. Also at each point of exam after discharge, age and sex matched control (who never had jaundice or any severe illness that may lead to neurological impairment) will be used for comparison.

Primary Outcome(s)

1. Number of exchange blood transfusions
2. Mortality

Children will be discharged from the study after the 36 months of age.

Secondary Outcome(s)

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.

Secondary ID(s)

KEMRI SCC 1016

Source(s) of Monetary Support

Collaborative Programme between: 1. Kenya Medical Research Institute (KEMRI) (Kenya) 2. The Wellcome Trust (UK) (grant ref: 077092)

Secondary Sponsor(s)

N/A