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European Newborn Study: Early Markers for a Better LifE

European Newborn Study: Early Markers for a Better LifE - ENSEMBLE

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON53431
Enrollment
240
Registered
2022-11-30
Start date
2023-10-06
Completion date
Unknown
Last updated
2025-11-17

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

Conditions

cerebral palsy cerebral palsy

Interventions

N.A.

Sponsors

Universitair Medisch Centrum Utrecht
Lead Sponsor

Eligibility

Age
No minimum to 11 Years

Inclusion criteria

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

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

Design outcomes

Primary

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

Secondary

MeasureTime frame
The development of recommendations to support parents in the process of disclosure of diagnosis and communication around prognosis of the development of their child, using questionnaires and interviews with parents.

Countries

France, Germany, Italy, Netherlands, Spain

Contacts

Public ContactM.L. Tataranno

Universitair Medisch Centrum Utrecht

secrneon@umcutrecht.nl088-7563308

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)