Early prediction of unilateral cerebral palsy in infants at risk: MRI versus the hand assessment for infants.
Nienke Wagenaar, Cornelia H Verhage, Linda S de Vries...
https://pubmed.ncbi.nlm.nih.gov/31722367Actively Recruiting
Age: 2Months - 11Months
All Genders
Healthy Volunteers
ID06396520
Neuroimaging of Babies During Natural Sleep to Assess Typical Development and Cerebral Palsy
Led by Danish Research Centre for Magnetic Resonance · Updated on 2026-01-28
200
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
D
Danish Research Centre for Magnetic Resonance
Lead Sponsor
H
Hvidovre University Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying early brain development in infants at risk for cerebral palsy (CP) and typically developing infants aged 3 to 24 months. The study aims to improve early diagnosis of CP by using advanced magnetic resonance imaging (MRI) techniques during natural sleep without sedation. It also seeks to understand how early brain development relates to motor function and development, providing important information for early intervention strategies. The study involves advanced MRI scans including diffusion-weighted imaging, high-resolution structural MRI, and MR spectroscopy, performed three times between 3 months and 2 years of age. Two groups participate: infants at high risk for CP recruited from the CP-EDIT trial and typically developing infants recruited specifically for this study. High-risk infants undergo MRI scans and parent questionnaires, while typically developing infants also receive neurological, motor, and cognitive assessments. Participants will attend three rounds of assessments at approximately 3-6 months, 12 months, and 24 months of age. Each visit includes MRI scans and various motor and cognitive tests such as Hand Assessments for Infants, Alberta Infant Motor Scale, and Bayley Scales of Infant Development, along with parent-reported questionnaires. Researchers will measure brain structure, connectivity, myelination, and metabolic profiles over time to identify early brain changes related to motor development and function. Safety monitoring includes minimizing infant discomfort with earplugs and headphones during MRI.
CONDITIONS
Brief Title
Neuroimaging of Babies During Natural Sleep to Assess Typical Development and Cerebral Palsy
Who Can Participate
Age: 2Months - 11Months
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Infants born preterm before 32 weeks or with birth weight below 1500 g (high-risk group)
- Infants with moderate to severe brain injury or significant neurological conditions
- Infants with history of neonatal seizures, ECMO, meningitis, kernicterus, or severe hypoglycemia
- Infants unable to sit independently by 9 months or showing hand or crawl asymmetry
- Typically developing infants born after 37 weeks with uneventful birth and no known neurological conditions
- Consent to share health information with medical doctors or primary care physician
You will not qualify if you...
- Infants with any MRI contraindications such as pacemakers or implanted electronic devices
- Families who do not speak or understand Danish
- Families who do not wish to be informed about incidental MRI findings or clinical assessment scores
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Diagnostic Evaluation
Duration - Up to 24 months with assessments at 3-6 months, 12 months, and 24 months
Participants undergo advanced MRI scans during natural sleep without sedation, including structural MRI, diffusion-weighted imaging, and MR spectroscopy to assess early brain development and detect brain injury.
3 visits (in-person) at approximately 3-6 months, 12 months, and 24 months of age
Long-term Monitoring
Duration - Up to 24 months with assessments at 3-6 months, 12 months, and 24 months
Participants are assessed with neurological, motor, cognitive tests, and parent-reported questionnaires alongside MRI scans to monitor developmental progress and brain changes over time.
3 visits (in-person) at approximately 3-6 months, 12 months, and 24 months of age
Trial Site Locations
Total: 1 location
1
Danish Research Centre for Magnetic Resonance
Hvidovre, Capital Region, Denmark, 2650
Actively Recruiting
Loading map...
Research Team
L
Line K Johnsen, PhD
K
Kathrine Skak Madsen, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
Published Research Related To This Trial
Dear reviewers: Responses to common reviewer critiques about infant neuroimaging studies.
Marta Korom, M Catalina Camacho, Courtney A Filippi...
https://pubmed.ncbi.nlm.nih.gov/34974250Evidence for embracing normative modeling.
Saige Rutherford, Pieter Barkema, Ivy F Tso...
https://pubmed.ncbi.nlm.nih.gov/36912775The normative modeling framework for computational psychiatry.
Saige Rutherford, Seyed Mostafa Kia, Thomas Wolfers...
https://pubmed.ncbi.nlm.nih.gov/35650452