Actively Recruiting

Age: 2Months - 11Months
All Genders
Healthy Volunteers
NCT06396520

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

Age: 2Months - 11Months
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

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
Not Eligible

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

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Trial Site Locations

Total: 1 location

1

Danish Research Centre for Magnetic Resonance

Hvidovre, Capital Region, Denmark, 2650

Actively Recruiting

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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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