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van CCT (UK)

van CCT (UK)

Study on Transfusion Effects in Preterm infants

- candidate number27757
- NTR NumberNTR6625
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR17-aug-2017
- Secondary IDsNL62348.042.17 University Medical Center Groningen
- Public TitleStudy on Transfusion Effects in Preterm infants
- Scientific TitleStudy on Transfusion Effects in Preterm infants
- hypothesisThe objective is to explore whether epo regulation and expression, at the age of two weeks after birth and three to six months post-term, are associated with the course of Hb levels, anemia, RBC transfusions, oxidative stress, and cerebral and intestinal oxygenation in preterm infants during the early neonatal period.
- Healt Condition(s) or Problem(s) studiedPreterm neonates, Anemia, Erythrocytes/Red blood cells, Epo
- Inclusion criteriaIn 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 criteriaA 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) < 5 at five minutes postpartum
- Major congenital malformations that increase the risk of death or adverse neurodevelopmental outcome (congenital cerebral malformations, congenital heart diseases excluding patent ductus arteriosus)
- Intraventricular and periventricular hemorrhage > 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
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-okt-2017
- planned closingdate1-nov-2018
- Target number of participants67
- InterventionsNone
- Primary outcomeThe 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 outcomeSecondary 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.
- TimepointsThe duration of the study will be from informed consent, followed by inclusion (after admission to the NICU) until three to six months post-term. The study period at the NICU will be for a maximum of four weeks. During the study period at the NICU the patients will undergo several non-invasive measurements.
- Trial web sitenot applicable
- statusplanned
- Sponsor/Initiator University Medical Center Groningen (UMCG)
- Funding
(Source(s) of Monetary or Material Support)
- Publications
- Brief summaryNeonatal anemia is common in preterm infants. Anemia may lead to hypoxia, possibly resulting in cell damage. A red blood cell (RBC) transfusion is an intervention aiming to rapidly improve oxygen transport to vital organs, such as the brain and the gut.
Anemia and RBC transfusions result in low and high organ oxygenation respectively. Both might be harmful, and especially high variation in oxygenation may lead to damage in vulnerable organs, such as the brain and the gut. As erythropoiesis is partly upregulated by hypoxia, there might be an association between these oxygenation values and the expression of erythropoietin (epo), which is the essential growth factor for the production of erythrocytes. Anemia leads to decreased oxygen transport and decreased organ oxygenation, whereas RBC transfusion increases oxygenation. It is unknown whether anemia and/or RBC transfusion are related to the expression of epo in gut cells through these various levels of oxygenation. We will therefore explore whether epo regulation and expression in intestinal cells may be associated with the course of hemoglobin (Hb) levels. Furthermore, we will explore if epo regulation and expression may also be associated with anemia, RBC transfusions, oxidative stress, and organ oxygenation in the neonatal period. Secondary, we will evaluate the clinical consequences and the neurological outcome of the variable oxygenation levels.
- Main changes (audit trail)
- RECORD17-aug-2017 - 22-okt-2017

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