Ignite Creation Date:
2025-12-24 @ 10:35 PM
Ignite Modification Date:
2026-01-22 @ 12:04 PM
Study NCT ID:
NCT03742635
Status:
COMPLETED
Last Update Posted:
2023-07-24
First Post:
2018-11-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Applying Prechtl's Assessment of General Movements for Preterm Infants Through Telemedicine
Sponsor:
University of California, Davis
Organization:
Study Overview
Official Title:
Feasibility and Reliability of Applying Prechtl's Assessment of General Movements for Preterm Infants Through Telemedicine
Status:
COMPLETED
Status Verified Date:
2023-07
Last Known Status:
None
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:
None
Brief Summary:
The investigators will implement a study to evaluate the hypothesis that applying General Movements Assessments (GMA) in a telemedicine setting with real-time scoring is feasible and comparable to scoring video recordings.
Detailed Description:
The investigators hypothesize that using telemedicine to conduct the GMA will improve early identification of risk for cerebral palsy and facilitate earlier referral and access to neurodevelopmental intervention. Preterm birth results from complex interactions of biological and socioeconomic risk factors, all of which continue to influence neurodevelopmental trajectories beyond the prenatal and neonatal period. Unfortunately many of the socioeconomic factors that contribute to increased risk of prematurity are also associated with decreased likelihood to attend appointments at high risk infant follow-up (HRIF) clinics. Early intervention has been shown to be most beneficial to infants with highest social risk. Additionally, mothers living in more rural communities tend to have higher social risk. They are often younger, more likely to be a single parent, and have lower income. Helping make follow-up more accessible and convenient for families through telemedicine and at an earlier age using the GMA has the potential to improve early identification, minimize loss to follow-up and ensure prompt referral to optimize outcomes for the most vulnerable babies in this already high-risk population.
Study Oversight
Has Oversight DMC:
False
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?: