The study population exists of prematures born after a gastational age of less than 32 weeks and 32-36 weeks with Apgar score <6, for whom at least 1 erythrocyte product is stored. The NICU is informed that this patient is a study candidate. The transfusion indications are decided by the treating physicians according to quidelines from the Dutch Society for Neonatology. In case the first transfusion is indicated the patient is randomly assigned to the autologous or an allogeneic red cell product
Conditions
Interventions
Transfusion of autologous red cord blood cell concentrate vs. transfusion of stored allogeneic red blood cell concentrates.
Sponsors
Project 945-04-609 of ZonM/w
Project OOPEP/1044 of Sanquin Blood supply
Eligibility
Inclusion criteria
Inclusion criteria: 1. Pregnant women; 2. Premature (gestational age of < 36 weeks) who require a red blood cell transfusion.
Exclusion criteria
Exclusion criteria: 1. Hemolytic disease of the newborn; 2. Maternal infections such as HIV/HCV/HBV/CMV/ Toxoplasma/ Treponema pallidum or maternal septicaemia; 3. Ruptured membranes >24 hr and body temp. >38 gr. C; 4. placenta praevia, version, solutio placentae; 5. antibiotics/fungostatica < 48 hr prior to partus.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients who received allogeneic transfusions and the total volume of administered allogeneic red cells. Days of support of vital functions in the NICU. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. 2 year and 5 years neurodevelopmental follow-up. | — |
Contacts
Public ContactA. Brand
Leiden University Medical Center (LUMC), P.0. Box 2184
Outcome results
None listed