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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03742635
Recruitment Status : Recruiting
First Posted : November 15, 2018
Last Update Posted : April 21, 2020
Sponsor:
Collaborator:
Children's Miracle Network
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Infant, Premature Other: General Movements Assessment Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 55 participants
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).
Masking: None (Open Label)
Primary Purpose: Screening
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Checkup

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Video recording reliability [ Time Frame: 9 months gestational age ]
    Inter-rater reliability of the video recording will be assessed using the Kappa statistic.

  2. Early referral [ Time Frame: 9 months gestational age ]
    Number of participants referred to targeted early intervention services, indicating early recognition of neurodevelopmental disability.



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 32 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03742635


Locations
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United States, California
University of California-Davis Recruiting
Sacramento, California, United States, 95817
Contact: Crystal Romero    916-734-0489    ccromero@ucdavis.edu   
Sponsors and Collaborators
University of California, Davis
Children's Miracle Network
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Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT03742635    
Other Study ID Numbers: 1288981
First Posted: November 15, 2018    Key Record Dates
Last Update Posted: April 21, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No