Early Family-Centered Intervention for Infants With High-Risk of Cerebral Palsy: Protocol for the Randomized Controlled GO-PLAY Trial

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Background. Early diagnosis of cerebral palsy (CP) is important to enable appropriate intervention at a time when neuroplasticity is at its highest. Early intervention with focus on family-centered, home-based, parent-involved, and supervised by specialist therapists show positive cognitive and motor outcomes. This study adhere to international guidelines for early diagnosis and intervention, and include community therapists to ensure regular follow-up during and after the intervention period. The aim of the current study is to compare the effectiveness of an early intervention program added to standard care, relative to standard care alone, on the early motor development in children from both a newborn and infant detectable risk pathway in a Danish multi-site setting. Methods. In a randomized, controlled trial the response to the GO-PLAY (Goal Oriented ParentaL supported home ActivitY) intervention program added to standard care is superior to standard care alone is evaluated. The investigators will include infants from the Cerebral Palsy - Early Diagnosis and Intervention Trial (CP-EDIT registered separately at ClinicalTrials) and collect data at baseline, after intervention and at follow up when the children are 2 years corrected age. The hypotheses are that the GO-PLAY intervention is more effective than standard care when the children are re-evaluated at the end of 6 months of intervention and that the parents involved in the GO-PLAY intervention will exhibit less signs of stress and anxiety and perceive the services that they are receiving as family-centered to a greater extent than parents of children receiving standard care. Discussion. Approximately half of all infants with high risk of CP display high risk indicators identifiable by early screening before 5 months of age described as the newborn detectable risk pathway. The other half of all infants with CP are detected by parents, caregivers or health care professionals when displaying delayed motor milestones (e.g. hand asymmetry or not sitting at 9 months) and described as infant detectable risk pathway. There is a need to investigate if early intervention is effective in all infants with high suspicion of CP, also the ones with unremarkable neonatal history. Further, a systematic early intervention has not been tested in infants at high risk of CP in Denmark, where public health services include physiotherapy free of charge for infants with CP.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 3 months
Maximum Age: 1
Healthy Volunteers: f
View:

⁃ Infants will be included in the intervention study, if they fulfil at least one of the requirements A or B:

⁃ A. any two of the following:

• Neuroimaging predictive of a motor disability including the involvement of one or more of the following structures: sensori-motor cortex, basal ganglia, posterior limb of the internal capsule, pyramidal tracts.

• General Movement Assessment with absent fidgety GMs at fidgety age

• HINE scores \<57 at 3months or \<60 at 6months or \<63 at 9 months or \<66 at 12 months

⁃ B. both of the following:

• Unilateral brain injury on neuroimaging (MRI or ultrasound) predictive of CP

• Clinical signs of asymmetry

Locations
Other Locations
Denmark
Aalborg University Hospital
RECRUITING
Aalborg
Aarhus University Hospital
RECRUITING
Aarhus
Contact Information
Primary
Mette Johansen
m.johansen1@rn.dk
+4530473915
Backup
Gija Rackauskaite, MD, PhD
gija.rackauskaite@auh.rm.dk
Time Frame
Start Date: 2023-04-01
Estimated Completion Date: 2028-03-31
Participants
Target number of participants: 60
Treatments
Active_comparator: Early intervention for infants
Early family-centered, individualized, goal-directed, intensive, and carried out within the home environment in a cross sectorial setting fortnightly contact shifting between at home visits and virtual meetings for 6 months after an interim diagnosis of CP or high risk of CP
Other: Usual care
Standard care consists rehabilitation offered by the local hospital/community or other private initiatives when diagnosed with CP or high risk of CP. The approach, frequency, and location (at home or rehabilitation centers) is varied
Related Therapeutic Areas
Sponsors
Leads: Rigshospitalet, Denmark
Collaborators: Aalborg University Hospital, Aarhus University Hospital

This content was sourced from clinicaltrials.gov