Anemia of the premature red blood cell shortage
Conditions
Interventions
None listed
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
16 Years to 64 Years
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: pregnant women admitted to the department of obstetrics in participating hospitals with a healthy term neonate, defined as a GA >=37 weeks can be screened for donation in one of the participating hospitals: EMC, LUMC and Maasstad Hospital. Donation criteria are based on the regular blood donor selection criteria for whole blood donation (Dutch Guideline for Donor Criteria: Richtlijn Donorkeuring, Sanquin ). Additional criteria have been made by a working party of our consortium, taking the particular situation into account involving both the pregnant woman as donor and the preterm recipient. Additional standards are formulated for screening for blood-borne infectious diseases and bacterial contamination as well as medication use that can cross the placentas barrier. Informed consent and donor screening is performed in the weeks leading up to birth by midwives, gynaecologists, research nurses and researchers at the obstetrics department. Transfusion requirements will be monitored of all extremely preterm neonates admitted to EMC and LUMC NICU of which the parents have given consent for use of clinical data for research purposes.
Exclusion criteria
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: • Unable to understand or refusing to sign an informed consent; • Do not pass donation criteria.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the number of CB-RBC products produced from CB donations that meet the quality requirements and release specifications according to the Dutch Guideline for Blood Products. In order to correlate the number of collected CB-RBCs to the neonatal transfusion need, the number of RBC transfusions required for neonates admitted to the EMC and LUMC Neonatal Intensive Care Unit (NICU) will be recorded as well. | — |
Countries
Netherlands
Contacts
Public ContactP. Snijder
Erasmus MC, Universitair Medisch Centrum Rotterdam
Outcome results
None listed