Implementation of Early Detection and Early Intervention Service Delivery in Infants at Risk for Cerebral Palsy to Promote Infants' Psychomotor Development and Maternal Health — BornTogether  

Cerebral Palsy Clinical Trial

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 Enrolling by invitation

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.

Clinical Trial 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) ;

Related Conditions & MeSH terms

• Cerebral Palsy

• NCT number: NCT04622787
• Study type: Observational
• Source: University of Pisa
• Status: Enrolling by invitation
• Start date: June 1, 2021
• Completion date: December 2023