Baby brain MRI during natural sleep to track early development and cerebral palsy risk

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.