The use of albumin to prevent exchange blood transfusions and improve outcome in neonates with severe hyperbilirubinaemia
| ISRCTN | ISRCTN89732754 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN89732754 |
| Protocol serial number | KEMRI SCC 1016 |
| Sponsor | Kenya Medical Research Institute (KEMRI) (Kenya) |
| Funders | Kenya Medical Research Institute (KEMRI) (Kenya), Wellcome Trust (grant ref: 077092) |
- Submission date
- 13/04/2007
- Registration date
- 16/04/2007
- Last edited
- 27/09/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Neonatal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Michael Mwaniki
Scientific
Scientific
PO Box 480
Kilifi
80108
Kenya
| mmwaniki@kilifi.kemri-wellcome.org |
Study information
| Primary study design | 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). |
| Secondary study design | Randomised controlled trial |
| Scientific title | The use of albumin to prevent exchange blood transfusions and improve outcome in neonates with severe hyperbilirubinaemia |
| Study objectives | 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(s) | Reviewed and approved by the Kenyan Nathional Ethics Review Committee on the 22nd Mwrch 2006 (ref: KEMRI SCC Protocol No 1016). |
| Health condition(s) or problem(s) studied | 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 / device / biological / vaccine name(s) | Albumin |
| Primary outcome measure(s) |
1. Number of exchange blood transfusions |
| Key secondary outcome measure(s) |
1. Neurological sequelae on discharge and at 12, 24 & 36 months of age. |
| Completion date | 30/05/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Neonate |
| Sex | All |
| Target sample size at registration | 62 |
| Total final enrolment | 118 |
| Key inclusion criteria | 1. Age 0 to 30 days 2. Bilirubin levels greater than 250 µmols/l 3. Neonates whose guardians consent to the study |
| Key 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 |
| Date of first enrolment | 01/06/2006 |
| Date of final enrolment | 30/05/2008 |
Locations
Countries of recruitment
- Kenya
Study participating centre
PO Box 480
Kilifi
80108
Kenya
80108
Kenya
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 23/09/2019 | 27/09/2019 | Yes | No |
Editorial Notes
27/09/2019: Publication reference and total final enrolment number added.
