Premature Umbilical Cord Blood (PUCB)

Completed

• Conditions: Anaemia of prematurity; Pregnancy and Childbirth; Other perinatal haematological disorders

• Registration Number: ISRCTN01566504
• Lead Sponsor: The Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-12-20
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 600

Inclusion Criteria

1. Pregnant women
2. Premature (gestational age of less than 36 weeks) who require a red blood cell transfusion

Exclusion Criteria

1. Haemolytic disease of the newborn
2. Maternal infections such as human immunodeficiency virus (HIV)/hepatitis C virus (HCV)/hepatitis B virus (HBV)/cytomegalovirus (CMV)/Toxoplasma/Treponema pallidum or maternal septicaemia
3. Ruptured membranes greater than 24 hours and body temp greater than 38°C
4. Placenta praevia, version, solutio placentae
5. Antibiotics/fungostatica less than 48 hours prior to partus

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Proportion of patients who received allogeneic transfusions and the total volume of administered allogeneic red cells<br>2. Days of support of vital functions in the NIC

Secondary Outcome Measures

Name	Time	Method
1. Days of assisted ventilation support<br>2. Cumulative complication incidence (infections, cerebral events) <br>3. Length of hospital stay<br>4. Mortality<br>5. Feasibility of erythrocyte collection from cord blood<br>6. Costs of transfusions<br>7. Costs of care<br>8. Two-year and five-year neurodevelopmental follow-up