Contact information
Type
Scientific
Primary contact
Dr Michael Mwaniki
ORCID ID
Contact details
P.O. Box 480
Kilifi
80108
Kenya
mmwaniki@kilifi.kemri-wellcome.org
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
KEMRI SCC 1016
Study information
Scientific title
Acronym
Study hypothesis
1. To determine if albumin can prevent exchange blood transfusions in neonates with severe hyperbilirubinaemia
2. To determine if albumin improves the outcome of neonates with severe hyperbilirubinaemia
Ethics approval
Reviewed and approved by the Kenyan Nathional Ethics Review Committee on the 22nd Mwrch 2006 (ref: KEMRI SCC Protocol No 1016).
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).
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Neonates with severe hyperbilirubinaemia
Intervention
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.
Intervention type
Drug
Phase
Not Specified
Drug names
Albumin
Primary outcome measure
1. Number of exchange blood transfusions
2. Mortality
Children will be discharged from the study after the 36 months of age.
Secondary outcome measures
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.
Overall trial start date
01/06/2006
Overall trial end date
30/05/2008
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Age 0 to 30 days
2. Bilirubin levels greater than 250 µmols/l
3. Neonates whose guardians consent to the study
Participant type
Patient
Age group
Neonate
Gender
Both
Target number of participants
62
Participant 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
Recruitment start date
01/06/2006
Recruitment end date
30/05/2008
Locations
Countries of recruitment
Kenya
Trial participating centre
P.O. Box 480
Kilifi
80108
Kenya
Sponsor information
Organisation
Kenya Medical Research Institute (KEMRI) (Kenya)
Sponsor details
P.O. Box 480
Kilifi
80108
Kenya
Sponsor type
Research organisation
Website
Funders
Funder type
Charity
Funder name
Collaborative Programme between:
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Kenya Medical Research Institute (KEMRI) (Kenya)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
The Wellcome Trust (UK) (grant ref: 077092)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list