Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06537622
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-10
Brief Title:
Best Practices Fo Early Diagnosis of Cerebral Palsy
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Implementation of Best Practices for Early Diagnosis of Cerebral Palsy CP in Very Preterm Infants a Stepped-wedge Cluster Randomized Controlled Trial RCT
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CP
Brief Summary:
In this research the investigators are using an implementation science approach to enhance the uptake of a clinical practice guideline for earlier diagnosis of cerebral palsy ie what is being implemented in neonatal follow-up clinics across Canada This clinical practice guideline should be part of what neonatal follow-up specialists do in their routine clinical work with children born preterm However there is a wide variability in practice The goal of this project is to harmonize practices in the neonatal follow-up community in agreement with international recommendations for earlier diagnosis of cerebral palsy This research will measure if clinicians are truly following the clinical practice guideline If not implementation strategies that address barriers and leverage on facilitators will be deployed for successful uptake of the clinical practice guideline This research will also assess whether implementation of the clinical practice guideline is associated with better patient outcomes
Detailed Description:
Children born preterm have an increased risk for brain-based disabilities including cerebral palsy CP with lower gestational age GA incurring higher vulnerability The rate of CP in very preterm children born before 29 weeks GA is 61The 2017 international recommendations for Early accurate diagnosis and early intervention in CP provides an evidence-based approach for prompt referral to targeted services to optimize child outcomes Early diagnosis and intervention during the optimal window of brain plasticity has the potential to improve developmental functioning Best practice guidelines also exist on how to convey an early diagnosis of CP in a compassionate way as poor communication can affect parental mental health The Canadian Neonatal Follow-Up Network CNFUN has partnered with the parent-led Canadian Premature Babies Foundation CPBF and key stakeholders to adapt these clinical practice guidelines to the Canadian context CPG-CP These CPG-CP promote the use of the General Movement Assessment GMA and the Hammersmith Infant Neurological Examination HINE for identification of early signs of CP The CPG-CP also propose clinical care pathways and an approach for communicating findings The overall goal of the CPG-CP is to improve clinicians ability to accurately recognize the earliest signs of CP that warrant immediate actions as opposed to a wait-and-see approach Using a hybrid effectiveness-implementation trial design the investigators will assess whether the implementation strategy is successful in increasing the uptake of the CPG-CP by CNFUN programs Concurrently the investigators will test the effectiveness of implementing the CPG-CP in detecting early signs of CP at a younger age in preterm infants born 29 weeks GA The investigators will secondarily compare whether using both the GMA and HINE is more performant than the HINE alone in identifying early signs of CP Finally the investigators will examine whether developmental functioning at 18-24 months corrected age CA improves after CPG-CP implementation
This proposal aims to reduce the gap in care related to the early identification of CP in children born very preterm across Canada Using a hybrid effectiveness-implementation study design the investigators will implement the CPG-CP in the real-world setting of CNFUN sites to improve clinicians ability to detect the early signs of CP in very preterm infants Early diagnosis enables the initiation of targeted interventions and engagement of support services Harnessing neuroplasticity through early and specific therapy can improve childrens overall development and functioning The effectiveness of the CPG-CP on improving clinical outcomes relies on a successful implementation process that considers the interplay between inner ie within neonatal follow-up programs outer eg local health care system and individual patient and clinician characteristics
This proposal aims to reduce the gap in care related to the early identification of CP in children born very preterm across Canada Using a hybrid effectiveness-implementation study design the investigators will implement the CPG-CP in the real-world setting of CNFUN sites to improve clinicians ability to detect the early signs of CP in very preterm infants Early diagnosis enables the initiation of targeted interventions and engagement of support services Harnessing neuroplasticity through early and specific therapy can improve childrens overall development and functioning The effectiveness of the CPG-CP on improving clinical outcomes relies on a successful implementation process that considers the interplay between inner ie within neonatal follow-up programs outer eg local health care system and individual patient and clinician characteristics
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None