Actively Recruiting
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
186 weeks
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
Background: Early diagnosis of cerebral palsy (CP) is crucial, enabling intervention when neuroplasticity is at its highest. Magnetic resonance imaging (MRI) plays a vital role in CP diagnosis. Currently, diagnostic MRI of newborns and infants with suspected brain damage relies heavily on structural MR images. The current study aims to i) establish procedures for clinical infant and toddler MRI during natural sleep, ii) use advanced MRI sequences, such as advanced diffusion-weighted imaging (DWI), that may be more sensitive in detecting early brain damage, and iii) map relationships between early brain development, and motor function and development. Methods: The NIBS-CP study will enroll approximately 200 infants either at risk for CP or typically developing. Infants will be followed longitudinally (for three waves) between 3 months and 2 years of age with cerebral MRI at 3 Tesla and comprehensive assessments of motor and cognitive functioning. The MRI protocol includes advanced diffusion-weighted imaging, high-resolution structural MRI, and MR spectroscopy. The motor and cognitive assessments include Hand Assessment in Infants, Alberta Infant Motor Scales, Hammersmith Infant Neurological Examination, Peabody Developmental Motor Scales, Bayley Scales of Infant Development, and Ages and Stages Questionnaires. NIBS-CP aims to establish normative material on early brain development of Danish children and conduct normative modeling of typical and atypical development to identify deviations in brain development at the level of the single child. Discussion: Identifying predictive brain structural features of motor function and motor development is key to the future use of early MRI in the clinical work-up, as this promotes early diagnosis and (clinical) intervention strategies tailored to the individual child.
CONDITIONS
Official Title
Neuroimaging of Babies During Natural Sleep to Assess Typical Development and Cerebral Palsy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- For infants at risk of cerebral palsy: born preterm before 32 weeks or with birth weight under 1500 g
- Moderate to severe brain injury or significant neurological conditions
- History of neurological risk factors like neonatal seizures, meningitis, kernicterus, or severe hypoglycemia
- Inability to sit independently by 9 months, hand or crawl asymmetry, or inability to bear weight on feet
- Consent to share relevant clinical information with medical doctors
- For typically developing infants: born after 37 weeks with uneventful birth
- No known brain injury or neurological condition
- Consent to share relevant clinical information with medical doctors
You will not qualify if you...
- Any contraindications for MRI such as pacemakers or implanted electronic devices
- Families who do not speak or understand Danish
- Families who do not want to be informed about incidental MRI findings or clinical assessment results
AI-Screening
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Trial Site Locations
Total: 1 location
1
Danish Research Centre for Magnetic Resonance
Hvidovre, Capital Region, Denmark, 2650
Actively Recruiting
Research Team
L
Line K Johnsen, PhD
CONTACT
K
Kathrine Skak Madsen, PhD
CONTACT
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
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