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

Danish Research Centre for Magnetic Resonance1 个研究点分布在 1 个国家目标入组 200 人开始时间: 2024年6月1日最近更新: 2026年1月28日

适应症

干预措施

试验速览

阶段: 不适用
状态: 招募中
发起方
入组人数: 200
试验地点: 1
主要终点: Brain volumetric measures

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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.

详细描述

Diagnostic magnetic resonance imaging (MRI) of newborns and infants with suspected brain damage is today based on conventional structural MR images with the focus on identifying major structural brain pathology. However, advanced MRI sequences, such as advanced diffusion-weighted imaging, may be more sensitive to detecting brain damage. The NeuroImaging of Babies during natural Sleep to assess typical development and CP (NIBS-CP) study is a longitudinal cohort study of infants and toddlers aged 3-24 months, aimed at studying early brain development in infants at risk of cerebral palsy (CP) and typically developing infants using advanced MRI sequences. The NIBS-CP cohort consists of:

Infants at risk for CP, recruited from the Cerebral Palsy: Early Diagnosis and Intervention Trial (CP-EDIT).

The ongoing Danish CP-EDIT by principal investigator Professor Christina Høi-Hansen is registered with ClinicalTrials.gov ID NCT05835674. CP-EDIT will enroll 160 infants aged 3-11 months with CP or high risk of CP. Infants will be followed longitudinally with a large battery of motor, neurological, and cognitive assessments during the first two years of life. In addition, CP-EDIT contains information from patient journals on diagnostic MRI, but CP-EDIT does not include the collection of MRI scans as part of the study. For infants enrolled in CP-EDIT, participation in NIBS-CP only includes advanced MRI scans and parent-reported questionnaires. All neurological, motor, and cognitive assessments will be undertaken in CP-EDIT. 2. Typically developing infants, recruited specifically for NIBS-CP. For these infants, participation in NIBS-CP includes advanced MRI scans, neurological, motor, and cognitive assessments (similar to the ones included in CP-EDIT), and parent-reported questionnaires. NIBS-CP provides a control cohort of typically developing infants that will give rise to a normative Danish sample of early brain development to the infants at high risk of CP, as CP-EDIT does not include a control cohort of typically developing infants.

AIMS

The NIBS-CP project aims to:

研究设计

研究类型: Observational
观察模型: Cohort
时间视角: Prospective

入排标准

年龄范围: 2 Months 至 11 Months（Child）
性别: All
接受健康志愿者: 是

入选标准

•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.

排除标准

•(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.

研究组 & 干预措施

Typically developing infants

Born after gestational week 37, Uneventful birth, No known history of brain injury, No known neurological disorders

干预措施: No intervention, observational (Other)

High Risk for Cerebral Palsy

Recruitment through CP-EDIT (Clinical trials.gov ID: NCT05835674), inclusion criteria.

'Newborn-detectable risk-pathway'. Preterm birth with gestational age below 32 or birth weight below 1500 g and clinical concern, Moderate to severe brain injury (Papile grade 3 to 4 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, Extra Corporal Membrane Oxygenation, meningitis, kernicterus, severe hypoglycemia) or neurological risk factors (brain malformation, increased tone), Parental concern and one of the factors above

'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 (as above) or neurological risk factors, Parental concern and one of the factors above.

干预措施: No intervention, observational (Other)