Cerebral PalsyBornTogetherNCT04622787
Implementation of Early Detection and Early Intervention Service Delivery in Infants at Risk for Cerebral Palsy to Promote Infants' Psychomotor Development and Maternal Health
An observational study of Cerebral Palsy, run by University of Pisa at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Knowledge translation
- How many people
- 500 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jun 2021to Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
Study population: 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.
Who may be able to join
- 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,
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
The overall aim of the study is to utilize Knowledge Translation strategies to disseminate culturally appropriate guidelines for early detection, surveillance, and early intervention for infants at risk for CP.
Primary objectives A1 To optimize the context-specific health programs for early detection of CP through the implementation of a tailored multifaceted knowledge translation strategy, in >500 infants with CP from Tuscany (Italy); Denmark; Netherlands, Georgia, Sri Lanka, and rural/ remote Australia (QLD, WA).
The investigators will also evaluate health care resource usage following the implementation of our translation strategy compared with a two-year period prior to the implementation- e.g. costs of early detection and targeted surveillance, targeting infants with CP (costs and consequences/outcomes of surveillance and intervention).
H1 Our hypothesis is that, compared with usual care, implementation of our translation strategy will increase the proportion of children that receive a diagnosis of CP <6 months of age from ~25% to >60%, as measured by CP Registers. Additional costs of screening and surveillance in our translation strategy will be off-set by targeting the highest risk babies earlier. Health care costs and usage will be focused on the most at-risk group, leading to improved outcomes across all children (costs/consequences analysis).
A2 To optimize the context-specific health programs for early surveillance of associated impairments and functional limitations of infants with CP, thereby fostering individualised (needs-based patient specific) early intervention and preventing secondary complications (e.g. hip dislocation, feeding disorders). The investigators will evaluate the early developmental trajectory of CP in infants aged 0-2 years and parental mental health to inform early intervention and surveillance needs to improve prediction of outcomes. The investigators will also compare the rates of hip displacement at 2 years following the implementation of our translation strategy compared with usual care (i.e. proportion of children with migration percentage >30%).
H2 Our hypothesis is that the natural history of CP in infants aged 0-2 years will differ according to motor severity, with different trajectories identified as early as 6 months' corrected age. The investigators also predict a reduction in the rate of hip displacement from 33% in current practice to <10% following the implementation of our translation strategy (consistent with Scandinavian screening programs).
A3 To optimize the context-specific health programs for early intervention in infants with CP, thereby improving the outcomes of both the infant and the caregivers. In Low- and Middle-Income Countries (LMIC) and hard-to-reach populations the investigators will also implement a community-based, parent delivered early intervention program for infants at high risk of CP (LEAP-CP).
H3 Our hypothesis is that infants with CP who receive the multi-domain intervention will have better motor development (Peabody DMS), social- emotional development on the Infant-Toddler Social Emotional Assessment (ITSEA), cognitive development (Bayley Scale of Infant Development (BSID III)) compared to infants receiving care as usual. Caregivers who receive the multi-domain intervention will have reduced scores on the Depression, Anxiety and Stress Scale compared to caregivers receiving care as usual.
Based on the aims listed above, there will be 3 parallel studies within the protocol:
A: Healthcare Providers Observational Study B: Infant Prospective Observational study C: Infant wait-list Randomised Controlled Trial of LEAP-CP, a home - based early intervention (Georgia, Sri-Lanka and remote Australia only, RCT (randomized controlled trial) registered separately with ANZCTR)
- Conditions
- Cerebral Palsy
- Being tested
- Knowledge translation
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Knowledge translationOther
- 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Knowledge translation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knowledge Translation effectiveness
Clinicians will be tested in survey format on their knowledge of the guidelines
Measured: through study completion, an average of 3 years
Secondary outcomes (1)
Infant age at diagnosis of Cerebral Palsy
change in average age at CP diagnosis at location before clinicians' trainings and up to 2 years after clinicians' trainings
Measured: through study completion, an average of 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2020
- Study start1 Jun 2021
- Primary completionJul 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pisa
- Sponsor type
- University, hospital or other
- Collaborators
- European Commission, National Health and Medical Research Council, Australia
- Responsible party
- Principal investigator, Andrea Guzzetta, University of Pisa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04622787
- Sponsor's protocol ID
- BornTogether
- Other IDs
- 848201
- Acronym
- BornTogether
- Status last verified
- Sep 2022
- First submitted
- 30 Jul 2020
- Last updated
- 7 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of Early Detection and Early Intervention Service Delivery in Infants at Risk for Cerebral Palsy to Promote Infants' Psychomotor Development and Maternal Health
- ClinicalTrials.gov ID
- NCT04622787
- Acronym / sponsor ID
- BornTogether / BornTogether
- Conditions
- Cerebral Palsy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University of PisaUniversity, hospital or other
- Collaborators
- European Commission, National Health and Medical Research Council, Australia
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- Jul 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 10 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The overall aim of the study is to utilize Knowledge Translation strategies to disseminate culturally appropriate guidelines for early detection, surveillance, and early intervention for infants at risk for CP.
Primary objectives A1 To optimize the context-specific health programs for early detection of CP through the implementation of a tailored multifaceted knowledge translation strategy, in >500 infants with CP from Tuscany (Italy); Denmark; Netherlands, Georgia, Sri Lanka, and rural/ remote Australia (QLD, WA).
The investigators will also evaluate health care resource usage following the implementation of our translation strategy compared with a two-year period prior to the implementation- e.g. costs of early detection and targeted surveillance, targeting infants with CP (costs and consequences/outcomes of surveillance and intervention).
H1 Our hypothesis is that, compared with usual care, implementation of our translation strategy will increase the proportion of children that receive a diagnosis of CP <6 months of age from ~25% to >60%, as measured by CP Registers. Additional costs of screening and surveillance in our translation strategy will be off-set by targeting the highest risk babies earlier. Health care costs and usage will be focused on the most at-risk group, leading to improved outcomes across all children (costs/consequences analysis).
A2 To optimize the context-specific health programs for early surveillance of associated impairments and functional limitations of infants with CP, thereby fostering individualised (needs-based patient specific) early intervention and preventing secondary complications (e.g. hip dislocation, feeding disorders). The investigators will evaluate the early developmental trajectory of CP in infants aged 0-2 years and parental mental health to inform early intervention and surveillance needs to improve prediction of outcomes. The investigators will also compare the rates of hip displacement at 2 years following the implementation of our translation strategy compared with usual care (i.e. proportion of children with migration percentage >30%).
H2 Our hypothesis is that the natural history of CP in infants aged 0-2 years will differ according to motor severity, with different trajectories identified as early as 6 months' corrected age. The investigators also predict a reduction in the rate of hip displacement from 33% in current practice to <10% following the implementation of our translation strategy (consistent with Scandinavian screening programs).
A3 To optimize the context-specific health programs for early intervention in infants with CP, thereby improving the outcomes of both the infant and the caregivers. In Low- and Middle-Income Countries (LMIC) and hard-to-reach populations the investigators will also implement a community-based, parent delivered early intervention program for infants at high risk of CP (LEAP-CP).
H3 Our hypothesis is that infants with CP who receive the multi-domain intervention will have better motor development (Peabody DMS), social- emotional development on the Infant-Toddler Social Emotional Assessment (ITSEA), cognitive development (Bayley Scale of Infant Development (BSID III)) compared to infants receiving care as usual. Caregivers who receive the multi-domain intervention will have reduced scores on the Depression, Anxiety and Stress Scale compared to caregivers receiving care as usual.
Based on the aims listed above, there will be 3 parallel studies within the protocol:
A: Healthcare Providers Observational Study B: Infant Prospective Observational study C: Infant wait-list Randomised Controlled Trial of LEAP-CP, a home - based early intervention (Georgia, Sri-Lanka and remote Australia only, RCT (randomized controlled trial) registered separately with ANZCTR)
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| 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 | – | Other: Knowledge translationMedical/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. |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- 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.
Key inclusion criteria (3 listed)
- 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,
Key exclusion criteria (14 listed)
- Not a healthcare provider or trainee
- Located (practicing) outside of study country locations
- Inclusion criteria: Infants aged <12 months' corrected age at with one of the following
- Extremely preterm
- Extremely low birthweight
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Knowledge translationA. 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. | Other | Medical professionals |
Primary outcome
Knowledge Translation effectiveness
Time frame: through study completion, an average of 3 years
Clinicians will be tested in survey format on their knowledge of the guidelines
1 secondary outcome
Infant age at diagnosis of Cerebral Palsy
Time frame: through study completion, an average of 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2022.
- The General Data Protection Regulation (GDPR)Link provided by the sponsor.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Palsy, run by University of Pisa at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knowledge Translation effectiveness (time frame: through study completion, an average of 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2022.