ISRCTN ISRCTN01566504
DOI https://doi.org/10.1186/ISRCTN01566504
Secondary identifying numbers NTR256
Submission date
20/12/2005
Registration date
20/12/2005
Last edited
14/11/2008
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Pregnancy and Childbirth
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof A. Brand
Scientific

Leiden University Medical Centre (LUMC)
P.O. Box 2184
Leiden
2301 CD
Netherlands

Phone +31 (0)71 568 5053
Email Anneke.Brand@bloodrtd.nl

Study information

Study designMulticentre, randomised, double-blind, active controlled, parallel group trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific titleThe use of autologous cord blood for anaemia of prematurity
Study acronymPUCB
Study objectivesCan 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(s)Received from the local medical ethics committee
Health condition(s) or problem(s) studiedAnaemia of prematurity
InterventionTransfusion of autologous red cord blood cell concentrate versus transfusion of stored allogeneic red blood cell concentrates.
Intervention typeOther
Primary outcome measure1. 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 measures1. 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 study start date01/12/2004
Completion date01/12/2007

Eligibility

Participant type(s)Patient
Age groupAdult
SexFemale
Target number of participants600
Key inclusion criteria1. Pregnant women
2. Premature (gestational age of less than 36 weeks) who require a red blood cell transfusion
Key exclusion criteria1. 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
Date of first enrolment01/12/2004
Date of final enrolment01/12/2007

Locations

Countries of recruitment

  • Netherlands

Study participating centre

Leiden University Medical Centre (LUMC)
Leiden
2301 CD
Netherlands

Sponsor information

The Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands)
Research organisation

P.O. Box 93245
Den Haag
2509 AE
Netherlands

Phone +31 (0)70 349 5111
Email info@zonmw.nl
Website http://www.zonmw.nl
ROR logo "ROR" https://ror.org/01yaj9a77

Funders

Funder type

Research organisation

The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)

No information available

Sanquin Bloodbank Amsterdam (The Netherlands)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan