eurodevelopmental Outcome after Fetal Neonatal Alloimmune Thrombocytopenia
Completed
- Conditions
- antibodies against platelets during pregnancy.Fetal neonatal alloimmune thrombocytopenia (FNAIT)100355341001684910012562
- Registration Number
- NL-OMON49430
- Lead Sponsor
- eids Universitair Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 63
Inclusion Criteria
- 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 Criteria
- Children born with congenital and/or chromosomal abnormalities.
- Children that passed away before inclusion.
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary outcome is cognitive development i.e., cognitive test score or<br /><br>Intelligence Quotient (IQ). </p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary outcome is neurodevelopmental impairment (NDI); a composite outcome<br /><br>including cerebral palsy Gross Motor Functioning Classification System (GMFCS)<br /><br>* II, cognitive and/or motor test score of less than 70 (-2 SD), hearing loss<br /><br>requiring amplification or visual impairment (legally certifiable as blind or<br /><br>partially sighted). Other secondary outcome parameters are HRQoL and behavioral<br /><br>functioning and the academic performance. The proportion of children with an<br /><br>abnormal course or incidence of infections, asthma, eczema and allergies will<br /><br>be assessed.</p><br>