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

NCT ID: NCT03742635

Last Updated: 2023-07-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 67 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-09
• Study Completion Date: 2023-02-28

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.

Conditions

Infant, Premature

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

GMA Assessment

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

Group Type: EXPERIMENTAL

General Movements Assessment

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

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.

• Maximum Eligible Age: 32 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Children's Miracle Network

OTHER

Sponsor Role: collaborator

University of California, Davis

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of California-Davis

Sacramento, California, United States

Countries

United States

Other Identifiers

1288981

Identifier Type: -

Identifier Source: org_study_id