Premature Umbilical Cord Blood (PUCB)

ISRCTN	ISRCTN01566504
DOI	https://doi.org/10.1186/ISRCTN01566504
Protocol serial number	NTR256
Sponsor	The Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands)
Funders	The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands), Sanquin Bloodbank Amsterdam (The Netherlands)

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

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

Primary study design	Interventional
Study design	Multicentre, randomised, double-blind, active controlled, parallel group trial
Secondary study design	Randomised controlled trial
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(s)	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
Key secondary outcome measure(s)	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
Completion date	01/12/2007

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	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

Leiden University Medical Centre (LUMC)

Leiden
2301 CD
Netherlands

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan