Feasibility and Reliability of Applying Prechtl's Assessment of General Movements for Preterm Infants Through Telemedicine

Applying Prechtl's Assessment of General Movements for Preterm Infants Through Telemedicine

Sponsors

Lead sponsor: University of California, Davis

Collaborator: Children's Miracle Network

Source University of California, Davis
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.

Overall Status Recruiting
Start Date January 9, 2019
Completion Date June 2022
Primary Completion Date December 2021
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Real-time versus video recording reliability 9 months gestational age
Secondary Outcome
Measure Time Frame
Video recording reliability 9 months gestational age
Early referral 9 months gestational age
Enrollment 55
Condition
Intervention

Intervention type: Other

Intervention name: General Movements Assessment

Description: 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.

Arm group label: GMA Assessment

Eligibility

Criteria:

Inclusion Criteria:

- All preterm infants who meet the High-Risk Infant Follow Up (HRIF) Criteria (less than 32 weeks gestational age or birth weight less than 1500 grams) who are cared for at UC Davis Medical Center

Exclusion Criteria:

- Families who are non-English speakers requiring a translator

- Families who are unable to access data-capable wireless service to participate in telemedicine visits through Zoom.

Gender: All

Minimum age: N/A

Maximum age: 32 Weeks

Healthy volunteers: No

Location
facility status contact University of California-Davis Crystal Romero 916-734-0489 [email protected]
Location Countries

United States

Verification Date

April 2020

Responsible Party

Responsible party type: Sponsor

Has Expanded Access No
Number Of Arms 1
Arm Group

Arm group label: GMA Assessment

Arm group type: Experimental

Description: Conduct General Movements Assessment (GMA) in-person/via-telemedicne ("real-time") and recorded (standard of care)

Patient Data No
Study Design Info

Allocation: N/A

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).

Primary purpose: Screening

Masking: None (Open Label)

Source: ClinicalTrials.gov