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

NCT03742635 | Completed

• 1 other identifier: 1288981
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

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.

Conditions

Infant, Premature

Outcome Measures

Primary Outcomes (1)

• Real-time versus video recording reliability

  Intra-rater reliability of GMA (real-time versus video recording) will be assessed using the Kappa statistic.

  9 months gestational age

Secondary Outcomes (2)

• Video recording reliability

  9 months gestational age

• Early referral

  9 months gestational age

Study Arms (1)

GMA Assessment

EXPERIMENTAL

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

Other: General Movements Assessment

Interventions

General Movements Assessment 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.

GMA Assessment

Eligibility Criteria

• Age: Up to 32 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, Davis: lead
• Children's Miracle Network: collaborator

Study Sites (1)

University of California-Davis

Sacramento, California, 95817, United States

Location

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Conduct General Movements Assessments (GMA) both in-person/via telemedicine ("real-time") and through recordings (standard of care).

Study Record Dates

• First Submitted: November 13, 2018
• First Posted: November 15, 2018
• Study Start: January 9, 2019
• Primary Completion: January 24, 2023
• Study Completion: February 28, 2023
• Last Updated: July 24, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)