Clinical trial NCT04622787: Implementation of Early Detection and Early Intervention Service Delivery in Infants at Risk for Cerebral Palsy to Promote Infants' Psychomotor Development and Maternal Health
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cerebral Palsy
Lead sponsor: University of Pisa
Sponsor class: OTHER
Collaborators: name: European Commission
name: National Health and Medical Research Council, Australia
First posted: 2020-11-10
Enrollment: 500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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.

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.

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)

Eligibility criteria: 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

Primary outcomes:
measure: Knowledge Translation effectiveness
timeFrame: through study completion, an average of 3 years
Secondary outcomes:
measure: Infant age at diagnosis of Cerebral Palsy
timeFrame: through study completion, an average of 3 years
Other outcomes:
Locations:
city: Pisa
country: Italy
facility: Universitá di Pisa
state: PI
Study officials:
References: