Status:
UNKNOWN
Neurodevelopmental Outcome After Fetal Neonatal AlloImmune Thrombocytopenia
Lead Sponsor:
Leiden University Medical Center
Collaborating Sponsors:
Sanquin-LUMC J.J van Rood Center for Clinical Transfusion Research
Conditions:
Fetal and Neonatal Alloimmune Thrombocytopenia
Long Term Adverse Effects
Eligibility:
All Genders
18-17 years
Brief Summary
Fetal and neonatal alloimmune thrombocytopenia (FNAIT) is a disease caused by allo-immunisation during pregnancy. If left untreated, FNAIT can lead to severe fetal intracranial haemorrhage. This compl...
Detailed Description
INTRODUCTION AND RATIONALE Fetal and neonatal alloimmune thrombocytopenia (FNAIT) is the most common cause of thrombocytopenia in otherwise healthy term-born neonates. FNAIT is a rare disease with an ...
Eligibility Criteria
Inclusion
- Children diagnosed with FNAIT during pregnancy or postnatal, at moment of inclusion 2 to 16 years of age.
- Children living in the Netherlands.
- Parents or guardian aged ≥ 18 years old, with parental authority.
- Written informed consent form both parents with, form being approved by Ethic Committee.
Exclusion
- Children born with congenital and/or chromosomal abnormalities.
- Children that passed away before inclusion.
Key Trial Info
Start Date :
December 17 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 17 2021
Estimated Enrollment :
78 Patients enrolled
Trial Details
Trial ID
NCT04529382
Start Date
December 17 2019
End Date
December 17 2021
Last Update
August 27 2020
Active Locations (1)
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1
Leiden University Medical Center
Leiden, Netherlands, 2333 ZA