Ignite Creation Date:
2024-05-06 @ 3:24 PM
Last Modification Date:
2024-10-26 @ 1:49 PM
Study NCT ID:
NCT04622787
Status:
UNKNOWN
Last Update Posted:
2022-09-07
First Post:
2020-07-30
Brief 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
Sponsor:
University of Pisa
Organization:
University of Pisa
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2022-09
Last Known Status:
ENROLLING_BY_INVITATION
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BornTogether
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- eg costs of early detection and targeted surveillance targeting infants with CP costs and consequencesoutcomes 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 costsconsequences 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 eg 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 ie 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
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- eg costs of early detection and targeted surveillance targeting infants with CP costs and consequencesoutcomes 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 costsconsequences 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 eg 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 ie 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 848201 | OTHER_GRANT | European Commission | None |