Natural History of Cerebral Palsy Prospective Study

Study Overview
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Brief Summary
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The study will describe the natural history of cerebral palsy (CP) as children develop over the first 2 years of life.

Detailed Description
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This study aims to describe the early natural history of cerebral palsy (CP) by mapping the development of infants with, or at-risk of CP, over the first two years of life. Infants will be assessed at regular intervals up to 24 months of age, across a variety of childhood development to provide the first comprehensive developmental trajectories of this group. In doing so, it will contribute to the existing knowledge of CP development to assist clinicians and therapists with accurate information on prognosis and provide targeted interventions early and at the 'just-right' challenge. Where indicated, individual participants' results from this study will be used to inform their therapy. This study is intended to form part of a larger multi-site international study.

Official Title
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Understanding the Early Natural History of Cerebral Palsy - A Prospective Cohort Study

Conditions
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Cerebral Palsy

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Infants will be included if they have a diagnosis of CP or at high risk of CP and under the age of 12 months. Infants at high risk of CP as defined by any two (any combination) of the following: Neuroimaging predictive of a motor disability including the involvement of 1 or more of the following structures: sensori-motor cortex, Basal Ganglia, Posterior Limb of the Internal Capsule, pyramids. Trajectory of cramped synchronized general movements (GMs) on General Movement Assessment (GMA) OR absent fidgety GMs at fidgety age Hammersmith Infant Neurological Exam (HINE) scores <57 @ 3months or <60 @ 6months or <63 @9 months Infants will also be included if they meet BOTH of the following criteria (even if infants have a HINE score greater than the cut off scores stated above: i. Unilateral brain injury on neuroimaging (magnetic resonance imaging (MRI) or cranial ultrasound (CUS)) predictive of CP ii. Clinical signs of asymmetry Exclusion Criteria: Infants with progressive or neurodegenerative disorders or genetic disorders not associated with CP Infants with other disability diagnoses e.g. Down Syndrome

Ages Eligible for Study
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Minimum Age: 3 Months
Maximum Age: 24 Months

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Children with or at high risk of CP<br>Infants with a diagnosis of CP OR at high risk of CP as per the international Clinical Practice Guideline for early diagnosis of CP. In order to develop prognostic curves for motor function a minimum of 3 data points are required per participant. For this reason infants will be included if they are 12 months or younger (corrected age) at the time of enrolment. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Motor skills | Peabody: Gross and Fine motor skills | 3 months, 6 months, 9 months, 12 months, 18 months, 24 months (corrected age) | 
| Change in Speech and Language skills | Bayley Scales of Infant and Toddler Development | 6 months, 9 months, 12 months, 18 months, 24 months (corrected age) | 
| Change in Cognitive skills | Bayley Scales of Infant and Toddler Development | 6 months, 9 months, 12 months, 18 months, 24 months (corrected age) | 
| Change in Neurologic assessment | Hammersmith Infant Neurological Examination | 3 months, 6 months, 9 months, 12 months, 18 months, 24 months (corrected age) | 
| Change in Musculoskeletal assessment | Modified Tardieu Scale | 3 months, 6 months, 9 months, 12 months, 18 months, 24 months (corrected age) | 
| Change in Musculoskeletal assessment | Australian Spasticity Assessment Scale | 9 months, 12 months, 18 months, 24 months (corrected age) | 
| Change in Musculoskeletal assessment | Hip X-ray | 18 months, 24 months corrected age | 
| Change in Vision | Previas | 6 months, 9 months, 12 months, 18 months, 24 months (corrected age) | 
| Vision | Ricci | 3 months corrected age | 
| Change in Sleep | Sleep disturbances Scale for Children | 9 months, 12 months, 18 months, 24 months (corrected age) | 
| Change in Feeding skills | Dysphagia Disorder Survey | 12 months, 18 months, 24 months (corrected age) | 
| Change in Self Care | Pediatric Evaluation of Disability Inventory Computerized Assessment Test | 6 months, 12 months, 18 months, 24 months (corrected age) | 
| Change in Adaptive Behavior | Infant Toddler Social Emotional Assessment | 12 months, 18 months, 24 months (corrected age) | 
| Change in Parent Well Being | Depression, Anxiety and Stress Scale | 12 months, 18 months, 24 months (corrected age) |