Taking peopleNo phase

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

Key facts

Who runs it: Copenhagen University Hospital, Rigshospitalet
Where: Denmark4 sites in 1 countryChoose a country to see its sites
Trial code: NCT05835674
Status: Recruiting
People taking part: 500 people, planned
Started: 1 Apr 2023
Expected to end: 31 Mar 2028
Type of study: Observational, 3 groups
Treatments tested: Early intervention program
Record updated: 28 April 2023

Who can take part

Age: 3 months to 12 months
Sex: Women and men
Healthy volunteers: Cannot take part

The registry criteria, word for word

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Who can take part

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

Who cannot take part

1) Infants with progressive or neurodegenerative disorders or genetic disorders not associated with CP, 2) Infants with other disability diagnoses e.g. Down Syndrome

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

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.

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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.

The 3 groups in the trial

Cohort I
500 participants screened by history and interview with parents to assess if they are to proceed to cohort II. This will be assessed by steering committee.
Cohort II
Participants (n=300) who meet the inclusion criteria from Cohort I, is assessed at enrollment visit and will proceed to cohort III if they meet any two of the following criteria: 1. Neuroimaging predictive of a motor disability 2. GMA test with absent fidgety GMs at fidgety age 3. HINE scores \<57 at 3months or \<60 at 6months or \<63 at 9 months or \< 66 at 12 months Infants will also be included if they meet both of the following criteria: 1. Unilateral brain injury on neuroimaging predictive of CP 2. Clinical signs of asymmetry Studies/objectives related to Cohort II 1. Evaluation of MRI 2. GMA implementation - To assess the feasibility of GMA in a multi-center Danish hospital setting. 3. Prediction of CP - To determine the clinical utility of the MRI, HINE, HAI, and GMA to predict a confirmed diagnosis of CP at 24 months 4. GMA/HINE/MRI vs. HAI - To compare diagnostic accuracy of HAI and GMA/HINE/MRI.
Cohort III
Participants (n=160) will be included in cohort III if infants are considered CP or at high risk of CP Participants are followed at enrolment, and ages six, 12, 18 and 24 months. Blood sample for trio-whole genome sequencing is offered to participants with definite or high risk of CP. Studies/objectives related to Cohort III e) Evaluation of genetics f) GO-PLAY. To analyse the effect of the GO-PLAY intervention with early family-centred set-up for children with definite or high risk of CP. g) Parents perspective on intervention. To explore parents' perspectives on barriers and facilitators involved in early intervention. h) Parents perspectives of early diagnosis - To analyse interviews of parents' perspectives of gains and concerns when having an early diagnosis of high risk of CP.
Treatment: Early intervention program