Condition category
Neonatal Diseases
Date applied
13/04/2007
Date assigned
16/04/2007
Last edited
04/03/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.kemri.org/

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes