Premature Umbilical Cord Blood (PUCB)
ISRCTN | ISRCTN01566504 |
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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
Scientific
Leiden University Medical Centre (LUMC)
P.O. Box 2184
Leiden
2301 CD
Netherlands
Phone | +31 (0)71 568 5053 |
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Anneke.Brand@bloodrtd.nl |
Study information
Study design | Multicentre, randomised, double-blind, active controlled, parallel group trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
Scientific title | The use of autologous cord blood for anaemia of prematurity |
Study acronym | PUCB |
Study objectives | 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(s) | Received from the local medical ethics committee |
Health condition(s) or problem(s) studied | Anaemia of prematurity |
Intervention | Transfusion of autologous red cord blood cell concentrate versus transfusion of stored allogeneic red blood cell concentrates. |
Intervention type | Other |
Primary outcome measure | 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 study start date | 01/12/2004 |
Completion date | 01/12/2007 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Sex | Female |
Target number of participants | 600 |
Key inclusion criteria | 1. Pregnant women 2. Premature (gestational age of less than 36 weeks) who require a red blood cell transfusion |
Key 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 |
Date of first enrolment | 01/12/2004 |
Date of final enrolment | 01/12/2007 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Leiden University Medical Centre (LUMC)
Leiden
2301 CD
Netherlands
2301 CD
Netherlands
Sponsor information
The Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands)
Research organisation
Research organisation
P.O. Box 93245
Den Haag
2509 AE
Netherlands
Phone | +31 (0)70 349 5111 |
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info@zonmw.nl | |
Website | http://www.zonmw.nl |
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 | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |