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

Not Applicable

Completed

• Conditions: eonates with severe hyperbilirubinaemia; Neonatal Diseases; Neonates with severe hyperbilirubinaemia

• Registration Number: ISRCTN89732754
• Lead Sponsor: Kenya Medical Research Institute (KEMRI) (Kenya)

Brief Summary

2019 results in: https://www.ncbi.nlm.nih.gov/pubmed/31547861 (added 27/09/2019)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-04-16
• Study Completion: 2008-05-30
• Last Update Posted: 29 October 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 118

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 1. Number of exchange blood transfusions<br> 2. Mortality<br><br> Children will be discharged from the study after the 36 months of age.<br>

Secondary Outcome Measures

Name	Time	Method
<br> 1. Neurological sequelae on discharge and at 12, 24 & 36 months of age.<br><br> Children will be discharged from the study after the 36 months of age.<br>