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

Not Applicable

Completed

• Conditions: Infant, Premature
• Interventions: Other: General Movements Assessment

• Registration Number: NCT03742635
• Lead Sponsor: 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.

Study Timeline

• Study First Submitted: 2018-11-13
• Study First Submitted QC: 2018-11-13
• Study First Posted: 2018-11-15
• Study Start: 2019-01-09
• Primary Completion: 2023-01-24
• Study Completion: 2023-02-28
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-21
• Last Update Posted: 2023-07-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 67

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Real-time versus video recording reliability	9 months gestational age	Intra-rater reliability of GMA (real-time versus video recording) will be assessed using the Kappa statistic.

Secondary Outcome Measures

Name	Time	Method
Video recording reliability	9 months gestational age	Inter-rater reliability of the video recording will be assessed using the Kappa statistic.
Early referral	9 months gestational age	Number of participants referred to targeted early intervention services, indicating early recognition of neurodevelopmental disability.

Trial Locations

Locations (1)

University of California-Davis; 🇺🇸 Sacramento, California, United States