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Preterm Oxygenation of the Cerebrum: Key for Erythrocyte-transfusion Threshold


- candidate number26778
- NTR NumberNTR6246
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR28-feb-2017
- Secondary IDsNL60383.042.17 University Medical Center Groningen
- Public TitlePreterm Oxygenation of the Cerebrum: Key for Erythrocyte-transfusion Threshold
- Scientific TitlePreterm Oxygenation of the Cerebrum: Key for Erythrocyte-transfusion Threshold
- ACRONYMPOCKET
- hypothesisOur primary objective is to test our hypothesis that a newly developed strategy with lower Hb thresholds for RBC transfusion than the current ones, provided adequate cerebral oxygen saturation values are met, will lead to a better neurological outcome in preterm infants at three monts post-term.
- Healt Condition(s) or Problem(s) studiedPreterm neonates, Anemia, Erythrocytes/Red blood cells
- 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
- Age between 0 and 7 days
- 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)
- Diagnosis of NEC prior to inclusion
- Intraventricular and periventricular hemorrhage > grade 2 according to Papile, 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 receivedno
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-apr-2017
- planned closingdate1-okt-2019
- Target number of participants194
- InterventionsThe intervention strategy group will not receive an RBC transfusion (15-20 ml/kg leukocyte-reduced erythrocytes) in case of an Hb threshold which is 1.0 mmol/l lower than current guidelines, i.e. at an Hb threshold of 7.0 mmol/L or 6.0 mmol/L depending on ventilatory support, unless cerebral regional tissue oxygen saturation is lower than 72% for at least 30 consecutive minutes during the first four weeks after birth, or until discharge. The control group will be treated according to the current strategy, following the current clinical NICU guidelines with the threshold for RBC transfusion: Hb < 8.0 mmol/L if the infant is ventilated, and Hb < 7.0 mmol/L if not.
- Primary outcomeThe primary outcome measure will be the neurological outcome at the age of three months post term, based on the motor optimality score (MOS) of the quality of General Movements (GMs).
- Secondary outcomeSecondary outcomes will be the incidence of in-hospital mortality and morbidities NEC, BPD, ROP, and deterioration of IVH assessed at 3 months post term age. Urinary I-FABP levels will be measured to determine intestinal cell damage as early marker for NEC. Cerebral regional tissue oxygen saturation and the total amount of RBC transfusions during the study period of 4 weeks will be recorded.
- TimepointsThe duration of the study will be from signed informed consent (after admission to the NICU) until three months post-term. The intervention period at the NICU will be for a maximum of four weeks. During the study period the infants will have several non-invasive measurements.
- Trial web sitenot applicable
- statusplanned
- CONTACT FOR PUBLIC QUERIES E.M.W. Kooi
- CONTACT for SCIENTIFIC QUERIES E.M.W. Kooi
- Sponsor/Initiator University Medical Center Groningen (UMCG)
- Funding
(Source(s) of Monetary or Material Support)
None
- Publications
- Brief summaryNeonatal anemia is common in preterm infants. During their stay in the neonatal intensive care unit, most of these high-risk infants receive at least one red blood cell (RBC) transfusion. The lack of knowledge on the balance of potential benefits and risk of RBC transfusion for anemic preterm infants, have led to controversies about the optimal threshold for RBC transfusion for this population.
We intend to conduct a randomized controlled trial, comparing two treatment strategies for RBC transfusion in preterm infants: We will compare a newly developed strategy for treatment of preterm anemia with the current treatment strategy. In the new strategy, transfusion Hb thresholds will be lower by 1 mmol/l compared to the current thresholds, provided adequate cerebral oxygen saturation values are met.
- Main changes (audit trail)
- RECORD28-feb-2017 - 29-apr-2017


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