BornTogether: 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 (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04622787
Collaborator
European Commission (Other), National Health and Medical Research Council, Australia (Other)
500
Enrollment
1
Location
30
Anticipated Duration (Months)
16.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or DiseaseIntervention/TreatmentPhase
  • Other: Knowledge translation

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

Study Type:
Observational
Anticipated Enrollment :
500 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
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
Anticipated Study Start Date :
Jun 1, 2021
Anticipated Primary Completion Date :
Jul 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

ArmIntervention/Treatment
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.

Other: Knowledge translation
A. 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.

Outcome Measures

Primary Outcome Measures

  1. Knowledge Translation effectiveness [through study completion, an average of 3 years]

    Clinicians will be tested in survey format on their knowledge of the guidelines

Secondary Outcome Measures

  1. Infant age at diagnosis of Cerebral Palsy [through study completion, an average of 3 years]

    change in average age at CP diagnosis at location before clinicians' trainings and up to 2 years after clinicians' trainings

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
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

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Universit√° di PisaPisaPIItaly56125

Sponsors and Collaborators

  • University of Pisa
  • European Commission
  • National Health and Medical Research Council, Australia

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Andrea Guzzetta, Associate Professor, University of Pisa
ClinicalTrials.gov Identifier:
NCT04622787
Other Study ID Numbers:
  • BornTogether
  • 848201
First Posted:
Nov 10, 2020
Last Update Posted:
Apr 14, 2021
Last Verified:
Nov 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 14, 2021