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Long-term neurodevelopmental outcome after perinatal arterial ischemic stroke

Long-term neurodevelopmental outcome after perinatal arterial ischemic stroke - LUNA

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON55959
Enrollment
50
Registered
2023-09-12
Start date
2023-11-15
Completion date
Unknown
Last updated
2025-09-08

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

Conditions

perinatal arterial ischemic stroke (PAIS)

Interventions

None listed

Sponsors

Universitair Medisch Centrum Utrecht
Lead Sponsor

Eligibility

Age
2 Years to 15 Years

Inclusion criteria

Inclusion criteria: - Children admitted to the NICU of the WKZ between September 2009 and March 2016 (aged 8-14 years during study participation), and diagnosed with PAIS with MRI; - Participant of the Neonatal Stroke Registry Utrecht; - Born at >=34 weeks of gestation; - A neonatal MRI was performed and is available for analysis.

Exclusion criteria

Exclusion criteria: - Preterm-born infants born before 34 weeks of gestation; - Other severe structural brain damage previously confirmed by neuro-imaging; - Congenital brain abnormalities and/or other (chromosomal/metabolic) anomalies; - Acquired brain injury due to trauma or infection

Design outcomes

Primary

MeasureTime frame
The primary endpoint will be neurodevelopmental, behavioral, executive, and language functioning after perinatal arterial ischemic stroke at 8-14 years of age.

Secondary

MeasureTime frame
Secondary endpoints will be brain growth and connectivity at school age after PAIS, the relation between neurodevelopmental outcomes and lesion topology, brain growth and connectivity, and changes in the rate of neurodevelopmental impairment after PAIS over time.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)