Clinical Trial

European Newborn Study: Early Markers for a Better LifE

Study acronym: ENSEMBLE
Recruiting
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Summary
The goal of this observational study is to create a computer model to help doctors predict any problems occurring during development of babies after being diagnosed with brain injury. This will help provide better care to future babies. Next to this, the experiences of parents or caregivers surrounding the first two years after birth of a baby at risk of developing cerebral palsy will be researched to develop recommendations to support parents. Parents of participants will: \- Fill in two online questionnaires, one when their child is 3-4 months corrected age. The second when their child is 2 years corrected age. For the child no additional tests are needed. Only tests that are part of standard clinical practice are performed and are also saved in the study database.
Trial Details
NCT Number NCT07189494
Lead Sponsor dr. M.J.N.L. Benders
Collaborators: Fondation Paralysie Cérébrale, Zoundream, CP Nederland, NeuroSpin
Conditions Cerebral Palsy
Enrollment 1,000 participants
Start Date 2023-10-06
Primary Completion 2029-01-01 (estimated)
Study Completion 2029-01-01 (estimated)
Updated on ClinicalTrials.gov 2025-09-24