Applying Prechtl's Assessment of General Movements for Preterm Infants Through Telemedicine
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|ClinicalTrials.gov Identifier: NCT03742635|
Recruitment Status : Recruiting
First Posted : November 15, 2018
Last Update Posted : April 21, 2020
|Condition or disease||Intervention/treatment||Phase|
|Infant, Premature||Other: General Movements Assessment||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||55 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Conduct General Movements Assessments (GMA) both in-person/via telemedicine ("real-time") and through recordings (standard of care).|
|Masking:||None (Open Label)|
|Official Title:||Feasibility and Reliability of Applying Prechtl's Assessment of General Movements for Preterm Infants Through Telemedicine|
|Actual Study Start Date :||January 9, 2019|
|Estimated Primary Completion Date :||December 2021|
|Estimated Study Completion Date :||June 2022|
Experimental: GMA Assessment
Conduct General Movements Assessment (GMA) in-person/via-telemedicne ("real-time") and recorded (standard of care)
Other: General Movements Assessment
Prechtl's Assessment of General Movements (GMA) is a tool used in early infancy to identify infants at high risk of cerebral palsy and neurodevelopmental impairment. General movements are complex motor patterns that involve the entire body, moving fluidly in different directions through the arms, legs, and trunk with variable speed, amplitude, force and intensity. During fetal development, spontaneously generated motor patterns, including general movements, can already be observed. The GMA is a functional assessment of the maturing nervous system that takes advantage of the fact that typically developing infants will have a progression in their general movements. This pattern is characterized by a writhing pattern in the early weeks post-term, followed by the emergence of fidgety movements at 3-5 months of age.
- Real-time versus video recording reliability [ Time Frame: 9 months gestational age ]Intra-rater reliability of GMA (real-time versus video recording) will be assessed using the Kappa statistic.
- Video recording reliability [ Time Frame: 9 months gestational age ]Inter-rater reliability of the video recording will be assessed using the Kappa statistic.
- Early referral [ Time Frame: 9 months gestational age ]Number of participants referred to targeted early intervention services, indicating early recognition of neurodevelopmental disability.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03742635
|United States, California|
|University of California-Davis||Recruiting|
|Sacramento, California, United States, 95817|
|Contact: Crystal Romero 916-734-0489 email@example.com|