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

A legfontosabb adatok

Ki végzi
Copenhagen University Hospital, Rigshospitalet
Hol
Dánia4 helyszín, 1 országbanVálassz országot a helyszínekhez
Azonosító
Állapot
Toboroz
Résztvevők
500 fő, tervezett
Kezdés
2023. ápr. 1.
Várható befejezés
2028. márc. 31.
A vizsgálat típusa
Megfigyeléses, 3 csoport
A vizsgált kezelések
  • Early intervention program
A regiszteradat frissítve
2023. április 28.

Ki vehet részt

Életkor
3 hónap – 12 hónap
Nem
Nők és férfiak
Egészséges önkéntesek
Nem vehetnek részt

A regiszter feltételei, szó szerint

Mind a 11 feltétel megnézéseKevesebb

Ki vehet részt

  • 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

Ki nem vehet részt

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

Ennek a vizsgálatnak nincs helyszíne itt: Egyesült Államok.

Egy országban van helyszíne. Válassz országot, hogy lásd a helyszíneket.

A vizsgálatról

Mit akar kideríteni a vizsgálat

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.

A teljes eredeti leírásKevesebb

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.

A vizsgálat 3 csoportja

  • 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.

    Kezelés: Early intervention program

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Contact the study team: see the registry record → Contacts and Locations

Oldal nyomtatása az orvosomnak

Adatok és források

Regiszteradat
Szerepel a ClinicalTrials.gov-on.
Hivatalos cím
Multi-center Prospective Cohort Study CP-EDIT: Cerebral Palsy - Early Diagnosis and Intervention Trial
Publikációk
A regiszteradat frissítve
2023. április 28.