NCT05835674 CP-EDIT: Cerebral Palsy - Early Diagnosis and Intervention Trial
| NCT ID | NCT05835674 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Rigshospitalet, Denmark |
| Condition | Cerebral Palsy |
| Study Type | OBSERVATIONAL |
| Enrollment | 500 participants |
| Start Date | 2023-04-01 |
| Primary Completion | 2025-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 500 participants in total. It began in 2023-04-01 with a primary completion date of 2025-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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 consecutively include a total of 500 infants. We will systematically collect data at inclusion and follow a subset of participants with definite cerebral palsy or high risk of cerebral palsy until they are two years of age. The focus is on eight areas related to implementation and the perspective of the families: Early MRI; early genetic testing; implementation of the General Movements Assessment method; early prediction of cerebral palsy; comparative analysis of the Hand Assessment for Infants method and evaluation by Hammersmith Infant Neurological Examination, MRI, and the General Movements method; analysis of the GO-PLAY early intervention; parental perspective of early intervention; and parental perspective of having an early diagnosis. Discussion Early screening for CP is increasingly possible and an interim diagnosis of "high risk of CP" is recommended but not currently used in our clinical care. There is a need to accelerate identification in mild or ambiguous cases to facilitate appropriate therapy early. The majority of studies on early diagnosis focus on identifying CP in infants below five months corrected age. Little is known about early diagnosis in the 50% of all CP cases that are discernible later in infancy, which is also addressed in this study. The study aims at improving care of patients with cerebral palsy even before they have the diagnosis established.
Eligibility Criteria
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 (≥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 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.
Contact & Investigator
Christina Hoei-Hansen, professor
STUDY CHAIR
Department of Paediatrics, University Hospital Rigshospitalet, Denmark
Frequently Asked Questions
Who can join the NCT05835674 clinical trial?
This trial is open to participants of all sexes, aged 3 Months or older, up to 12 Months, studying Cerebral Palsy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05835674 currently recruiting?
Yes, NCT05835674 is actively recruiting participants. Contact the research team at christina.hoei-hansen@regionh.dk for enrollment information.
Where is the NCT05835674 trial being conducted?
This trial is being conducted at Aalborg, Denmark, Aarhus, Denmark, Herlev, Denmark, Copenhagen, Denmark.
Who is sponsoring the NCT05835674 clinical trial?
NCT05835674 is sponsored by Rigshospitalet, Denmark. The principal investigator is Christina Hoei-Hansen, professor at Department of Paediatrics, University Hospital Rigshospitalet, Denmark. The trial plans to enroll 500 participants.
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