Implementation of Early Detection and Early Intervention Service Delivery in Infants at Risk for Cerebral Palsy to Promote Infants' Psychomotor Development and Maternal Health
BornTogether
2 other identifiers
observational
500
1 country
1
Brief Summary
The BORNTOGETTHERE consists of improving health programs for early detection and surveillance of Cerebral Palsy (CP) by implementing the first International Clinical Practice Guidelines (Novak et al, 2017) in multiple sites in Europe (Italy, Denmark, Netherlands), in low- and middle-income countries (Georgia, Sri Lanka) and hard to reach populations (Remote Queensland, QLD and Western Australia, WA). In addition, exploiting early detection of infants at very high risk of CP, the investigators will implement best-evidence knowledge on early intervention in CP, thereby improving the outcomes of the infants and of their caregivers.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2021
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 30, 2020
CompletedFirst Posted
Study publicly available on registry
November 10, 2020
CompletedStudy Start
First participant enrolled
June 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2023
CompletedSeptember 7, 2022
September 1, 2022
2.1 years
July 30, 2020
September 5, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Knowledge Translation effectiveness
Clinicians will be tested in survey format on their knowledge of the guidelines
through study completion, an average of 3 years
Secondary Outcomes (1)
Infant age at diagnosis of Cerebral Palsy
through study completion, an average of 3 years
Study Arms (7)
Tuscany, Italy
Infants at risk of Cerebral Palsy in Tuscany, Italy
Infants at risk of Cerebral Palsy in Georgia
Infants at risk of Cerebral Palsy in Georgia
Sri-Lanka
Infants at risk of Cerebral Palsy in Sri-Lanka
Denmark
Infants at risk of Cerebral Palsy in Denmark
Infants at risk of Cerebral Palsy in the Netherlands
the Netherlands
remote Queensland, Australia
Infants at risk of Cerebral Palsy in remote Queensland, Australia
Medical professionals
Medical/healthcare providers from all involved geographic locations that work with infants at risk or with diagnosis of cerebral palsy will be provided opportunities for the participation in face-to-face and/or e-learning platform trainings on the the international early detection guidelines.
Interventions
A. Healthcare Providers Observational Study - measure of the effectiveness of the International Guidelines training courses (face to face and online) delivered to medical professionals (involves all clinical partners). The International Guidelines training courses on the evidence-based principles of Early Detection (ED), Early surveillance (ES), and Early intervention (EI) will be delivered to healthcare providers. Face-to-face professional trainings will be set up at each Consortium partner location. E-learning platform will allow for training and follow-up resources will be available to clinicians in all languages that are spoken/written in the locations of the Consortium partners. Clinicians will be assessed on their knowledge and standard clinical practices in survey format before trainings and after the trainings.
Eligibility Criteria
Healthcare providers Knowledge Translation: Medical/healthcare providers that work with infants at risk or with diagnosis of cerebral palsy in involved countries Infant and family observational study: Infants aged \<12 months' corrected age until 24 months of age.
You may qualify if:
- Medical/healthcare provider or advanced trainee
- Works with infants at risk or with diagnosis of cerebral palsy
- Practices in Georgia, Sri-Lanka, The Netherlands, Denmark, Remote Queensland region of Australia, Tuscan region of Italy,
You may not qualify if:
- Not a healthcare provider or trainee
- Located (practicing) outside of study country locations
- Infant and family observational study:
- Extremely preterm
- Extremely low birthweight
- Neonatal encephalopathy
- Stroke
- Abnormal General Movements with abnormal brain neuroimaging
- Abnormal General Movements with abnormal Neurological Evaluation
- Abnormal brain neuroimaging with abnormal Neurological Evaluation
- Lethal abnormalities
- congenital conditions not associated with cerebral palsy (e.g. Down's Syndrome)
- complex medical conditions requiring acute medical care
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Pisalead
- European Commissioncollaborator
- National Health and Medical Research Council, Australiacollaborator
Study Sites (1)
Universitá di Pisa
Pisa, PI, 56125, Italy
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
July 30, 2020
First Posted
November 10, 2020
Study Start
June 1, 2021
Primary Completion
July 1, 2023
Study Completion
December 1, 2023
Last Updated
September 7, 2022
Record last verified: 2022-09
Data Sharing
- IPD Sharing
- Will not share
The Coordinator (and data controller) of BORNTOGEtTHERe will not collect personal data from the Consortium Partners. Personal data will be collected within each participating institution and stored locally according to Pseudonymized data will be provided from the participating partner institutions to the data controller (The Coordinator) for the BORNTOGEtTHERe project.