NL-OMON48979CompletedNot Applicable
Study on Transfusion Effects in Preterm infants - STEP-trial
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 67
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 2 to 11 (—)
Inclusion Criteria
- •- gestational age < 32 weeks
- •- before 7 days of age
- •- written informed consent by legal representative(s)
Exclusion Criteria
- •- Chromosomal abnormality (e.g. trisomy 13, 18, 21)
- •- Perinatal asphyxia resulting in Apgar score (AS) < 5 at five minutes
- •- 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
Investigators
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