Baby brain MRI during natural sleep to track early development and cerebral palsy risk
Neuroimaging of Babies During Natural Sleep to Assess Typical Development and Cerebral Palsy
We will try advanced MRI scans while infants sleep naturally to see if they reveal early brain differences in babies at risk for cerebral palsy and in typically developing infants.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 2 Months to 11 Months |
| Sex | All |
| Sponsor | Danish Research Centre for Magnetic Resonance Academic / other |
| Locations | 1 site (Hvidovre, Capital Region) |
| Trial ID | NCT06396520 on ClinicalTrials.gov |
What this trial studies
This is a longitudinal observational cohort that will enroll about 200 infants (at-risk and typically developing) and follow them across three visits between roughly 3 months and 2 years of age. Participants will undergo 3 Tesla MRI during natural sleep using advanced sequences, including diffusion-weighted imaging, alongside standardized motor and cognitive assessments. The study includes infants recruited from a linked CP-EDIT cohort and local Danish clinical sites and collects imaging and parent-reported measures but no interventions. The goal is to map how early brain imaging markers relate to later motor and cognitive development and to refine procedures for clinical infant MRI during natural sleep.
Who should consider this trial
Good fit: Ideal candidates are infants aged about 3–24 months who are either at increased risk for cerebral palsy (for example very preterm birth, very low birthweight, moderate–severe neonatal brain injury, or early motor asymmetry/failure to sit) or typically developing infants for comparison, and who can tolerate MRI during natural sleep and attend longitudinal visits in Denmark.
Not a fit: Infants with contraindications to MRI (for example implanted metal devices), unstable medical conditions, those outside the 3–24 month window, or families unable to travel to the Danish imaging site are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the approach could enable earlier and more sensitive detection of brain injury related to cerebral palsy, allowing earlier targeted intervention during a high-plasticity window.
How similar studies have performed: Conventional structural neonatal MRI and some diffusion MRI studies have previously helped identify brain injury related to CP, but the use of advanced diffusion sequences during natural sleep in a longitudinal infant cohort is relatively novel and less established.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria High-Risk population: Group: 'Newborn-detectable risk-pathway' * Preterm birth with gestational age below 32 weeks * Birth weight below 1500 g * Moderate to severe brain injury (A label of moderate to severe brain injury was considered if there was Papile grade three to four intraventricular haemorrhage, cystic periventricular leukomalacia, neonatal stroke, term hypoxic-ischaemic encephalopathy (≥35 weeks gestation at birth) or other significant neurological condition) * History (e.g., neonatal seizures, ECMO, meningitis, kernicterus, severe hypoglycemia) or neurological risk factors (malformations in CNS, increased tone) Group: 'Infant detectable risk-pathway' * Inability to sit independently by age 9 months * Hand function asymmetry or crawl asymmetry * Inability to take weight through the plantar surface of the feet * History (e.g., as above) or neurological risk factors Additional inclusion criteria for inclusion in NIBS-CP for both CP-risk groups: \- Consent to health-relevant information on clinical findings being passed on to the medical doctors in CP-EDIT and/or their primary care physician. Inclusion Criteria Typically developing infant population: * Born \>37 weeks * Uneventful birth * No known history of brain injury * No neurological condition * Consent to health-relevant information on clinical findings being passed on to their primary care physician or relevant medical doctors, e.g., neuropaediatrician. Exclusion Criteria (all groups): * Infants have any MRI contraindications, e.g., pacemaker or other implanted electronic devices. * Families do not speak or understand Danish. * Families do not wish to be informed about incidental findings on the MRI, or scores within the clinical range in the neurological, motor, or cognitive assessments.
Where this trial is running
Hvidovre, Capital Region
- Danish Research Centre for Magnetic Resonance — Hvidovre, Capital Region, Denmark (Recruiting)
Study contacts
- Principal investigator: Kathrine Skak Madsen, PhD — Senior Researcher
- Study coordinator: Line K Johnsen, PhD
- Email: linekj@drcmr.dk
- Phone: +4561145571
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.