Hoei-Hansen, Christina Engel
Weber, Lene
Johansen, Mette
Fabricius, Rebecca
Hansen, Jonas Kjeldbjerg
Viuff, Anne-Cathrine F.
Rønde, Gitte
Hahn, Gitte Holst
Østergaard, Elsebet
Duno, Morten
Larsen, Vibeke Andrée
Madsen, Camilla Gøbel
Røhder, Katrine
Elvrum, Ann-Kristin Gunnes
Laugesen, Britt
Ganz, Melanie
Madsen, Kathrine Skak
Willerslev-Olsen, Maria
Debes, Nanette Mol
Christensen, Jan
Christensen, Robin
Rackauskaite, Gija
Funding for this research was provided by:
Royal Library, Copenhagen University Library
Article History
Received: 31 March 2023
Accepted: 14 September 2023
First Online: 30 October 2023
Declarations
:
: The study protocol follows the Helsinki Declaration and written informed consent will be collected prior to inclusion from all participating healthy controls and patients. The Committees on Health Research Ethics in the Capital Region of Denmark (reference number: H-22013292) and the Danish Data Protection Agency (P- P-2022-980) have approved the study. All parents will receive oral and written information about the study by a physician or a therapist with specialized knowledge of the study project.The study is associated with a low risk of side effects and discomfort. There could be some discomfort with blood sampling, but this is considered a routine procedure and measures will be taken to minimise pain. With the genetic analysis there may arise incidental findings not related to CP. Participants will be informed in advance of the risk of incidental genetic findings, and they will be handled as otherwise addressed by the guidelines of the Danish National Genome Center. MRI is a non-invasive imaging method with no known biological hazards and safe to use in children. There may be some discomfort by MRI scanning, due to the loud scanning environment, or—if used—some minor risk associated with general anaesthesia, but this is also a routine procedure and will be performed by clinicians trained in handling children. Incidental MRI findings not related to CP may arise. With the testing of motor function there may be a small risk of adverse events, e.g., sprained ankle. There could also arise anxiety for parents by having a diagnosis of high risk of CP, which will be addressed, and they will be referred to a psychologist if they wish.Consent will be requested from parents to data sharing from CP-EDIT to the BornToGetThere database (j.nr. H-19041562) and with other international collaborators after obtaining data transfer agreements.
: Not applicable for this protocol paper.
: The authors declare no competing interests.