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Neuroimaging of Babies During Natural Sleep to Assess Typical Development and Cerebral Palsy

Recruitingn/aAges 2 Months - 11 MonthsAllDanish Research Centre for Magnetic Resonance
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In plain words

What the trial is, and whether it could suit you

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 c

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 (โ‰ฅ35 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.
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What it tests

  • No intervention, observational
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Where

1 site
Danish Research Centre for Magnetic Resonance
Hvidovre, Denmark
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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