Clinical Trial Details
— Status: Enrolling by invitation
Administrative data
| NCT number |
NCT04622787 |
| Other study ID # |
BornTogether |
| Secondary ID |
848201 |
| Status |
Enrolling by invitation |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
June 1, 2021 |
| Est. completion date |
December 2023 |
Study information
| Verified date |
September 2022 |
| Source |
University of Pisa |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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 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.
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)
