Contact information
Type
Scientific
Primary contact
Prof A. Brand
ORCID ID
Contact details
Leiden University Medical Centre (LUMC)
P.O. Box 2184
Leiden
2301 CD
Netherlands
+31 (0)71 568 5053
Anneke.Brand@bloodrtd.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NTR256
Study information
Scientific title
The use of autologous cord blood for anaemia of prematurity
Acronym
PUCB
Study hypothesis
Can allogeneic red cell transfusions for preterm/very low birth weight newborns be reduced and is this associated with favourable outcome of usual neonatal complications (infections, cerebral bleeding, duration of assisted ventilation and death) resulting in shortening of the need of vital support necessitating Neonatal Intensive Care Unit (NICU) care.
Ethics approval
Received from the local medical ethics committee
Study design
Multicentre, randomised, double-blind, active controlled, parallel group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Anaemia of prematurity
Intervention
Transfusion of autologous red cord blood cell concentrate versus transfusion of stored allogeneic red blood cell concentrates.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
1. Proportion of patients who received allogeneic transfusions and the total volume of administered allogeneic red cells
2. Days of support of vital functions in the NICU
Secondary outcome measures
1. Days of assisted ventilation support
2. Cumulative complication incidence (infections, cerebral events)
3. Length of hospital stay
4. Mortality
5. Feasibility of erythrocyte collection from cord blood
6. Costs of transfusions
7. Costs of care
8. Two-year and five-year neurodevelopmental follow-up
Overall trial start date
01/12/2004
Overall trial end date
01/12/2007
Reason abandoned
Eligibility
Participant inclusion criteria
1. Pregnant women
2. Premature (gestational age of less than 36 weeks) who require a red blood cell transfusion
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
600
Participant 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
Recruitment start date
01/12/2004
Recruitment end date
01/12/2007
Locations
Countries of recruitment
Netherlands
Trial participating centre
Leiden University Medical Centre (LUMC)
Leiden
2301 CD
Netherlands
Sponsor information
Organisation
The Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands)
Sponsor details
P.O. Box 93245
Den Haag
2509 AE
Netherlands
+31 (0)70 349 5111
info@zonmw.nl
Sponsor type
Research organisation
Website
Funders
Funder type
Research organisation
Funder name
The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Sanquin Bloodbank Amsterdam (The Netherlands)
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