Preterm neonates, Anemia, Erytrhocytes/Red blood cells, Erythropoietin
Conditions
Interventions
None
Sponsors
University Medical Center Groningen (UMCG)
Eligibility
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: - A gestational age < 32 weeks - Before 7 days of age - Written informed consent by legal representative(s)
Exclusion criteria
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: - Chromosomal abnormality (e.g. trisomy 13, 18, 21) - Perinatal asphyxia resulting in Apgar score (AS) grade 2 according to Papile, prior to inclusion - Diagnosis of NEC prior to inclusion - Alloimmune hemolytic disease, sickle-cell disease or thalassemia - Any received RBC transfusions prior to inclusion - Inability to understand Dutch by the parents - Parents expressing strong philosophical or religious objections to transfusion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome measure will be epo regulation and expression at various ages: baseline epo concentration in umbilical cord blood, epo concentration in blood at the age of two weeks after birth, the degree of DNA methylation in intestinal cells isolated from feces at the age of two weeks after birth, and the degree of DNA methylation in intestinal cells isolated from feces at the age of three to six months post-term. Additionally, if one of the included infants developed NEC and needs surgery, then a small part of the removed intestine will be analysed in laboratory for intestinal epo gene expression, comparing it with an healthy part which is already available in the laboratory. Furthermore, we will use Hb levels assessed during standard care and collect information (number and volume) regarding RBC transfusions during the first four weeks of life. Cerebral and intestinal oxygen saturation during the first four weeks after birth and urinary isoprostane concentrations, as biomarker for oxidative stress, will also be determined. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes will be cerebral and intestinal rSO2, urinary I-FABP concentration before and after RBC transfusion, and the prevalence of NEC and its grading at 40 weeks postmenstrual age (PMA). Furthermore, we will assess the neurological condition using the assessment of general movements (GMs) before and after the first RBC transfusion, and the neurological outcome at the age of three months post-term, based on the motor optimality score (MOS) of the quality of the GMs. | — |
Contacts
Public ContactE.M.W. Kooi
UMCG
Outcome results
None listed