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Clinical Trials/NL-OMON48979
NL-OMON48979
Completed
Not Applicable

Study on Transfusion Effects in Preterm infants - STEP-trial

niversitair Medisch Centrum Groningen0 sites67 target enrollmentTBD
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Conditionsneurologische ontwikkelingAnemia and low red blood cell count1000208610017969

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
neurologische ontwikkeling
Sponsor
niversitair Medisch Centrum Groningen
Enrollment
67
Status
Completed
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
last year
Study Type
Observational non invasive

Investigators

Eligibility Criteria

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

Outcomes

Primary Outcomes

Not specified

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