Neurodevelopmental Outcome after Fetal Neonatal Alloimmune Thrombocytopenia

Neurodevelopmental Outcome after Fetal Neonatal Alloimmune Thrombocytopenia - NO FNAIT

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON49430

Enrollment

Registered

2019-10-02

Start date

2019-12-17

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

antibodies against platelets during pregnancy. Fetal neonatal alloimmune thrombocytopenia (FNAIT)

Interventions

None listed

Eligibility

Age

2 Years to 17 Years

Inclusion criteria

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

Exclusion criteria: - Children born with congenital and/or chromosomal abnormalities. - Children that passed away before inclusion.

Design outcomes

Primary

Measure	Time frame
The primary outcome is cognitive development i.e., cognitive test score or Intelligence Quotient (IQ).	—

Secondary

Measure	Time frame
Secondary outcome is neurodevelopmental impairment (NDI); a composite outcome including cerebral palsy Gross Motor Functioning Classification System (GMFCS) * II, cognitive and/or motor test score of less than 70 (-2 SD), hearing loss requiring amplification or visual impairment (legally certifiable as blind or partially sighted). Other secondary outcome parameters are HRQoL and behavioral functioning and the academic performance. The proportion of children with an abnormal course or incidence of infections, asthma, eczema and allergies will be assessed.	—

Measure

Time frame

Secondary outcome is neurodevelopmental impairment (NDI); a composite outcome including cerebral palsy Gross Motor Functioning Classification System (GMFCS) * II, cognitive and/or motor test score of less than 70 (-2 SD), hearing loss requiring amplification or visual impairment (legally certifiable as blind or partially sighted). Other secondary outcome parameters are HRQoL and behavioral functioning and the academic performance. The proportion of children with an abnormal course or incidence of infections, asthma, eczema and allergies will be assessed.

—

Countries

Netherlands

Outcome results