Condition category
Pregnancy and Childbirth
Date applied
20/12/2005
Date assigned
20/12/2005
Last edited
14/11/2008
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

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

http://www.zonmw.nl

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

Publication citations

Additional files

Editorial Notes