Infant, PrematureNCT03742635
Applying Prechtl's Assessment of General Movements for Preterm Infants Through Telemedicine
A study testing General Movements Assessment in people with Infant, Premature, run by University of California, Davis at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 32 weeks
- Conditions the study is for
- Infant, Premature
- What is being tested?
- General Movements Assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jan 2019to 28 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 32 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California-Davis
Sacramento, California, 95817
About this study
Official title: Feasibility and Reliability of Applying Prechtl's Assessment of General Movements for Preterm Infants Through Telemedicine
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.
Read the 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
- Being tested
- General Movements Assessment
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
General Movements AssessmentOther
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.
| Study group | Role | What they receive |
|---|---|---|
| GMA Assessment | Experimental | Conduct General Movements Assessment (GMA) in-person/via-telemedicne ("real-time") and recorded (standard of care) Receives: Other: General Movements Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Real-time versus video recording reliability
Intra-rater reliability of GMA (real-time versus video recording) will be assessed using the Kappa statistic.
Measured: 9 months gestational age
Secondary outcomes (2)
Video recording reliability
Inter-rater reliability of the video recording will be assessed using the Kappa statistic.
Measured: 9 months gestational age
Early referral
Number of participants referred to targeted early intervention services, indicating early recognition of neurodevelopmental disability.
Measured: 9 months gestational age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2018
- Study start9 Jan 2019
- Primary completion24 Jan 2023
- Study completion28 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infant, PrematureStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Conduct General Movements Assessments (GMA) both in-person/via telemedicine ("real-time") and through recordings (standard of care).
- Masking
- None (open label)
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Miracle Network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03742635
- Sponsor's protocol ID
- 1288981
- Status last verified
- Jul 2023
- First submitted
- 13 Nov 2018
- Last updated
- 24 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Reliability of Applying Prechtl's Assessment of General Movements for Preterm Infants Through Telemedicine
- ClinicalTrials.gov ID
- NCT03742635
- Acronym / sponsor ID
- 1288981
- Conditions
- Infant, Premature
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Collaborators
- Children's Miracle Network
- Study start
- 9 Jan 2019 (actual)
- Primary completion
- 24 Jan 2023 (actual)
- Study completion
- 28 Feb 2023 (actual)
- First posted
- 15 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Conduct General Movements Assessments (GMA) both in-person/via telemedicine ("real-time") and through recordings (standard of care).
| Arm | Type | Receives |
|---|---|---|
| GMA Assessment | Experimental | Other: General Movements AssessmentConduct General Movements Assessment (GMA) in-person/via-telemedicne ("real-time") and recorded (standard of care) |
Who may qualify
- Ages
- Up to 32 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| General Movements AssessmentPrechtl'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. | Other | GMA Assessment |
Primary outcome
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.
2 secondary outcomes
Video recording reliability
Time frame: 9 months gestational age
Early referral
Time frame: 9 months gestational age
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing General Movements Assessment in people with Infant, Premature, run by University of California, Davis at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Real-time versus video recording reliability (time frame: 9 months gestational age). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2023.