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CP-EDIT: Cerebral Palsy - Early Diagnosis and Intervention Trial

Recruitingn/aAges 3 Months - 12 MonthsAllCopenhagen University Hospital, Rigshospitalet
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In plain words

What the trial is, and whether it could suit you

Background. Early diagnosis of cerebral palsy is important as intervention becomes possible at a time where neuroplasticity is at the highest. Current mean age at diagnosis is 13 months in Denmark. Recent research has documented that implementation of an early-diagnosis set-up can lower diagnostic age of cerebral palsy. The aim of the current study is to show that the response to the early intervention program added to standard care is superior to standard care alone in a Danish multi-site setting in children from both a newborn and infant detectable risk pathway. Methods The current study CP-EDIT (Early Diagnosis and Intervention Trial) with the GO-PLAY intervention included (Goal Oriented ParentaL supported home ActivitY program), aims at testing feasibility of an early diagnosis and intervention set-up in four paediatric centers. In a prospective cohort study design, we will consecut

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๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: Group A: '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 (โ‰ฅ35 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 Group B: '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 Exclusion Criteria: * 1\) Infants with progressive or neurodegenerative disorders or genetic disorders not associated with CP, 2) Infants with other disability diagnoses e.g. Down Syndrome.
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What it tests

  • Early intervention program
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Where

4 sites
University Hospital Aalborg
Aalborg, Denmark
University Hospital Aarhus
Aarhus, Denmark
University Hospital Herlev
Herlev, Denmark
University Hospital Rigshospitalet, Dept. Paediatrics
Copenhagen, 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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