Implementation of Early Detection and Early Intervention Service Delivery in Infants at Risk for … (NCT04622787) | Clinical Trial Compass
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Implementation of Early Detection and Early Intervention Service Delivery in Infants at Risk for Cerebral Palsy to Promote Infants' Psychomotor Development and Maternal Health
Italy500 participantsStarted 2021-06-01
Plain-language 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.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Healthcare providers Knowledge Translation:
Inclusion Criteria:
* 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,
Exclusion Criteria:
* Not a healthcare provider or trainee
* Located (practicing) outside of study country locations
Infant and family observational study:
Inclusion criteria: Infants aged \<12 months' corrected age at with one of the following
* 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
Exclusion criteria
* Lethal abnormalities
* congenital conditions not associated with cerebral palsy (e.g. Down's Syndrome)
* complex medical conditions requiring acute medical care
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Knowledge Translation effectiveness
Timeframe: through study completion, an average of 3 years