Ignite Creation Date:
2025-12-24 @ 10:35 PM
Ignite Modification Date:
2026-01-22 @ 12:04 PM
Study NCT ID:
NCT03742635
Status:
COMPLETED
Last Update Posted:
2023-07-24
First Post:
2018-11-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Applying Prechtl's Assessment of General Movements for Preterm Infants Through Telemedicine
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D047928', 'term': 'Premature Birth'}], 'ancestors': [{'id': 'D007752', 'term': 'Obstetric Labor, Premature'}, {'id': 'D007744', 'term': 'Obstetric Labor Complications'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Conduct General Movements Assessments (GMA) both in-person/via telemedicine ("real-time") and through recordings (standard of care).'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 67}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2023-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-21', 'studyFirstSubmitDate': '2018-11-13', 'studyFirstSubmitQcDate': '2018-11-13', 'lastUpdatePostDateStruct': {'date': '2023-07-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-11-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Real-time versus video recording reliability', 'timeFrame': '9 months gestational age', 'description': 'Intra-rater reliability of GMA (real-time versus video recording) will be assessed using the Kappa statistic.'}], 'secondaryOutcomes': [{'measure': 'Video recording reliability', 'timeFrame': '9 months gestational age', 'description': 'Inter-rater reliability of the video recording will be assessed using the Kappa statistic.'}, {'measure': 'Early referral', 'timeFrame': '9 months gestational age', 'description': 'Number of participants referred to targeted early intervention services, indicating early recognition of neurodevelopmental disability.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Infant, Premature']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '32 Weeks', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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\n\nExclusion Criteria:\n\n* Families who are non-English speakers requiring a translator\n* Families who are unable to access data-capable wireless service to participate in telemedicine visits through Zoom.'}, 'identificationModule': {'nctId': 'NCT03742635', 'briefTitle': "Applying Prechtl's Assessment of General Movements for Preterm Infants Through Telemedicine", 'organization': {'class': 'OTHER', 'fullName': 'University of California, Davis'}, 'officialTitle': "Feasibility and Reliability of Applying Prechtl's Assessment of General Movements for Preterm Infants Through Telemedicine", 'orgStudyIdInfo': {'id': '1288981'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'GMA Assessment', 'description': 'Conduct General Movements Assessment (GMA) in-person/via-telemedicne ("real-time") and recorded (standard of care)', 'interventionNames': ['Other: General Movements Assessment']}], 'interventions': [{'name': 'General Movements Assessment', 'type': 'OTHER', 'description': "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.", 'armGroupLabels': ['GMA Assessment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95817', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'University of California-Davis', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Davis', 'class': 'OTHER'}, 'collaborators': [{'name': "Children's Miracle Network", 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}