Cerebral Palsy – Early Diagnosis and Intervention Trial: protocol for the prospective multicentre CP-EDIT study with focus on diagnosis, prognostic factors, and intervention

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  • Lene Weber
  • Mette Johansen
  • Rebecca Fabricius
  • Jonas Kjeldbjerg Hansen
  • Anne Cathrine F. Viuff
  • Gitte Rønde
  • Gitte Holst Hahn
  • Morten Duno
  • Vibeke Andrée Larsen
  • Camilla Gøbel Madsen
  • Ann Kristin Gunnes Elvrum
  • Britt Laugesen
  • Kathrine Skak Madsen
  • Robin Christensen
  • Gija Rackauskaite
Background
Early diagnosis of cerebral palsy (CP) is important to enable intervention at a time when neuroplasticity is at its highest. Current mean age at diagnosis is 13 months in Denmark. Recent research has documented that an early-diagnosis set-up can lower diagnostic age in high-risk infants. The aim of the current study is to lower diagnostic age of CP regardless of neonatal risk factors. Additionally, we want to investigate if an early intervention program added to standard care is superior to standard care alone.

Methods
The current multicentre study CP-EDIT (Early Diagnosis and Intervention Trial) with the GO-PLAY intervention included (Goal Oriented ParentaL supported home ActivitY program), aims at testing the feasibility of an early diagnosis set-up and the GO-PLAY early intervention. CP-EDIT is a prospective cohort study, consecutively assessing approximately 500 infants at risk of CP. We will systematically collect data at inclusion (age 3–11 months) and follow a subset of participants (n = 300) with CP or at high risk of CP until the age of two years. The GO-PLAY early intervention will be tested in 80 infants with CP or high risk of CP.

Focus is on eight areas related to implementation and perspectives of the families: early cerebral magnetic resonance imaging (MRI), early genetic testing, implementation of the General Movements Assessment method, analysis of the GO-PLAY early intervention, parental perspective of early intervention and early diagnosis, early prediction of CP, and comparative analysis of the Hand Assessment for Infants, Hammersmith Infant Neurological Examination, MRI, and the General Movements method.

Discussion
Early screening for CP is increasingly possible and an interim diagnosis of “high risk of CP” is recommended but not currently used in clinical care in Denmark. Additionally, there is a need to accelerate identification in mild or ambiguous cases to facilitate appropriate therapy early. Most 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. The current study aims at improving care of patients with CP even before they have an established diagnosis.

Trial registration
ClinicalTrials.gov ID 22013292 (reg. date 31/MAR/2023) for the CP-EDIT cohort and ID 22041835 (reg. date 31/MAR/2023) for the GO-PLAY trial.
OriginalsprogEngelsk
Artikelnummer544
TidsskriftBMC Pediatrics
Vol/bind23
Udgave nummer1
Antal sider14
ISSN1471-2431
DOI
StatusUdgivet - 2023

Bibliografisk note

Funding Information:
Open access funding provided by Royal Library, Copenhagen University Library The study is funded by the Elsass Foundation (grant no. 21-B01-1192 and 22-B01-0664), Rigshospitalets 1-årige introduktionsstipendium (grant no RH-E-2251–03), Danske Fysioterapeuters forskningsfond, Region Nordjyllands Sundhedsvidenskabelige Forskningsfond, and the Dronning Louise foundation.

Funding Information:
Study protocol is version CP-EDIT_290323 The study is funded by the Elsass Foundation (grant no. 21-B01-1192 and 22-B01-0664), The Research Fund of Rigshospitalet (grant no RH-E-2251–03), The Association of Danish Physiotherapists Research Fund, Region Nordjyllands Sundhedsvidenskabelige Forskningsfond, and the Dronning Louise foundation. The study funders have no influence on the study.

Publisher Copyright:
© 2023, The Author(s).

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