European Newborn Study: Early Markers for a Better LifE

Recruiting

• Conditions: 10010335; cerebral palsy

• Registration Number: NL-OMON53431
• Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 240

Inclusion Criteria

-All infants with confirmed brain injury on MRI at high risk for cerebral palsy.
-Written informed parental consent (Dutch, English, French, German, Italian,
Spanish).

Exclusion Criteria

-Infants not matching the inclusion criteria
-Any proven or suspected severe congenital anomaly, genetic or metabolic
disorder
-Presence of an infection of the central nervous system
-Parents < 18 years old
-Not being able to read one of the six Informed Consent languages

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The creation of a ML algorithm (including standard clinical care assessment:<br /><br>MRI, EEG, and clinical data collected up to 3 months of age, including GMA and<br /><br>HINE) being able to early predict motor, behavioral, cognitive outcome. The<br /><br>creation and implementation of automated tools to analyze these early<br /><br>assessments in at-risk infants to obtain a more precise, individualized<br /><br>diagnosis and prognosis of CP based on harmonized scans and protocols (GMFCS,<br /><br>BSID-III, CBCL).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The development of recommendations to support parents in the process of<br /><br>disclosure of diagnosis and communication around prognosis of the development<br /><br>of their child, using questionnaires and interviews with parents.</p><br>