[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659481":3},{"organization":4,"outcomesModule":7,"designInfo":25,"detailedDescription":28,"studyPopulation":29,"armGroups":30,"interventions":24,"overallOfficials":24,"centralContacts":24,"locations":37,"responsibleParty":76,"collaborators":80,"id":85,"slug":86,"hasResults":87,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":24,"eligibilityCriteria":91,"healthyVolunteers":87,"sex":92,"minAge":93,"maxAge":94,"enrollmentInfo":95,"targetDuration":24,"studyType":98,"phases":24,"briefSummary":99,"conditions":100,"keywords":105,"overallStatus":112,"whyStopped":24,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":122},{"fullName":5,"class":6},"Shirley Ryan AbilityLab","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":24},[9,13],{"measure":10,"description":11,"timeFrame":12},"3-month Screening Performance (Aims 1-2, Toolkit Development cohort)","Screening performance of the toolkit at 3 months (internal validation)","3 months",{"measure":14,"description":15,"timeFrame":12},"3-month Screening Performance (Aim 3; Toolkit Validation cohort)","Screening performance of the toolkit at 3 months (external validation)",[17,21],{"measure":18,"description":19,"timeFrame":20},"12-month Screening Performance (Aims 1-2; Toolkit Development cohort)","Screening performance of the toolkit at 12 months (internal validation)","12 months",{"measure":22,"description":23,"timeFrame":20},"12-month Screening Performance (Aim 3; Toolkit Validation cohort)","Screening performance of the toolkit at 12 months (external validation)",null,{"allocation":24,"interventionModel":24,"interventionModelDescription":24,"primaryPurpose":24,"observationalModel":26,"timePerspective":27,"maskingInfo":24},"COHORT","PROSPECTIVE","Study visits will include clinical assessments and sensor data collection sessions to test and monitor their motor development over time. The frequency and length of study visits will vary depending on what group the participant is recruited into.\n\nParticipating children in the Toolkit Development cohort (Aim 1) will complete up to 7 study visits from birth to 3 months corrected age. Sensor visits will occur biweekly and assessment visits will occur monthly. Follow-up visits will be completed at 12 and 24-months corrected age. Data from this cohort will be used to develop and internally test the toolkit (Aim 2).\n\nParticipating children in the Toolkit Validation cohort (Aim 3) will complete biweekly sensor visits from birth to 3 months corrected age (up to 7 visits). In this cohort, the child may continue testing monthly from 4-11 months corrected age (\"Surveillance group\", up to 8 visits; see below). A follow-up visit will be completed at 12-months corrected age for all participants in the Toolkit Validation cohort. Data from this cohort will be used to validate and refine the toolkit for optimized performance and clinical utility. Children will be assigned to the Surveillance group under this aim, to continue monthly sensor and assessment visits from 4-11 months corrected age, if either of the following occur: (1) The toolkit disagrees with the specialist assessment at 3-months corrected age. (2) If the toolkit identifies the participating child as at risk for motor deficits any time between birth and 3-months corrected age.\n\nFor any cohort, the study team will place up to 6 sensors on the child's body and head to observe the participating child's movement. Skin checks will be performed before and after placing the sensors. These visits will take place in participants' home and in the community. There are two components of the sensor visits: Observed Activities and Free-Living Activities. During Observed Activities, the study team will observe the caregiver and participating child during any common daily activities for at least 30 minutes, targeting up to 60 minutes. The study team may ask caregivers to support their child as needed during these activities. During Free-Living Activities, the caregiver will continue to monitor and log their child's activities and behaviors for up to 12 hours. Caregivers will be given a GoPro camera and tripod to record their child's activities inside and outside the home, to their comfort. Caregivers will also be given a manual log to document any activities that the caregivers do not want or are not able to capture on video. The study team will not be present throughout this component. The sensors, log, and GoPro will be picked up the next day or at families earliest convenience","infants who are at risk of motor or other developmental delay",[31,33,35],{"label":32,"type":24,"description":24,"interventionNames":24},"Infants 0-3 Months Old at Risk for Motor Delay (Aim 1)",{"label":34,"type":24,"description":24,"interventionNames":24},"Infants 0-3 Months Old at Risk for Motor Delay Surveillance Group (Aim 3)",{"label":36,"type":24,"description":24,"interventionNames":24},"Infants 0-3 Months Old at Risk for Motor Delay Non-Surveillance Group (Aim 3)",[38,61],{"facility":39,"status":24,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"Shirley Ryan Abilitylab","Chicago","Illinois","60611","United States","US",{"type":46,"coordinates":47},"Point",[48,49],-87.65005,41.85003,{"lat":49,"lon":48},[52,57],{"name":53,"role":54,"phone":55,"phoneExt":24,"email":56},"Megan O'Brien, PhD","CONTACT","(312) 238-2289","mobrien02@sralab.org",{"name":58,"role":54,"phone":59,"phoneExt":24,"email":60},"Anushua Banerjee","312-238-7721","abanerjee@sralab.org",{"facility":62,"status":24,"city":40,"state":41,"zip":63,"country":43,"countryCode":44,"cosmosGeoPoint":64,"geoPoint":66,"contacts":67},"University of Illinois at Chicago","60612",{"type":46,"coordinates":65},[48,49],{"lat":49,"lon":48},[68,72],{"name":69,"role":54,"phone":70,"phoneExt":24,"email":71},"Nishant Srinivasan, MD","312-996-4185","srinis@uic.edu",{"name":73,"role":54,"phone":74,"phoneExt":24,"email":75},"Zaynab Kadhem","312-355-4038","zkadhe2@uic.edu",{"type":77,"investigatorFullName":78,"investigatorTitle":79,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"PRINCIPAL_INVESTIGATOR","Megan O'Brien","Principal Investigator",[81,84],{"name":82,"class":83},"Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)","NIH",{"name":62,"class":6},"100659481","wearable-sensor-toolkit-for-infant-motor-development-100659481",false,"NCT07866495","Wearable Sensor Toolkit for Infant Motor Development","A Wearable Sensor Toolkit for Automated Home Evaluations of Infant Motor Development","Inclusion Criteria:\n\nThe study population comprises infants who are at risk of motor or other developmental delay. \"At-risk\" is defined as having been admitted to the NICU admission and qualifying for Early Childhood Clinic (NICU high-risk follow up clinic) or Early Intervention due to:\n\n* BW \\\u003C1500 grams OR\n* Disorders of the central nervous system\n* Brain injury (including but not limited to extra axial hemorrhage, any grade intraventricular or intraparenchymal hemorrhage, stroke, hypoxic ischemic encephalopathy (HIE), meningitis)\n* HIE includes mild, moderate, severe exam on modified Sarnat exam, both cooled and non-cooled\n* includes \"at risk for HIE\" with 10-minute Apgar \\\u003C7 plus pH\\\u003C7.15 or base deficit \\>\u002F=12.\n* Brain developmental abnormalities (hydrocephalus, microcephaly, cortical dysgenesis)\n* Cramped synchronous movements at term PMA (post-menstrual age) OR\n* Bronchopulmonary dysplasia (BPD) defined as need for respiratory support at 36 weeks postmenstrual age in an infant born at \\\u003C32 weeks of gestation.\n\nAND\n\n\\- Medically stable (as determined by their neonatologist) AND able to begin study procedures between 34-48 weeks PMA.\n\nExclusion Criteria:\n\n* Open wounds, skin condition precluding sensor placement\n* Immune deficiencies requiring protective isolation\n* Limb reduction defects\n* Followed primarily in another clinic (including but not limited to meningomyelocele and related conditions\u002Ftrisomy 21)\n* Bleeding disorders or ongoing need for anticoagulation\n* Palliative or hospice care (for life limiting conditions including, but not limited to trisomy 18, 13)\n* Known visual impairment at the time of enrollment\n* DCFS custody\n* No English-speaking caregivers\n* Any other condition that would preclude participation in the study, as determined by the PI\n* Previously enrolled in competing randomized trial with developmental outcome variables","ALL","0 Days","52 Weeks",{"count":96,"type":97},90,"ESTIMATED","OBSERVATIONAL","The purpose of this study is to develop and test a fully automated, wireless sensor-based toolkit for infants that can capture early indicators (0-3 months) of motor deficits during activities of daily life and track motor development over the course of one year.\n\nThe investigators expect that the participating child will be in this research study for up to 12-24 months corrected-age depending on which group the participating child is recruited into.\n\nThe main benefit of being in this study is to help monitor the participating child's motor development.\n\nThe investigators will place up to 6 sensors on the participants body and head to observe the participants child's movement. Caregivers will also be trained to place the sensors. The sensors will send movement information wirelessly to an iPad or smartphone, using Bluetooth technology.",[101,102,103,104],"Motor Delay","Infant Development","Motor Development of Premature Infants","Motor Coordination or Function; Developmental Disorder",[106,107,108,109,110,111],"Infant","Motor Development","Home Visits","Infant Motor Delay","0-3 Months","Risk of Motor Delay in Infants","NOT_YET_RECRUITING","2026-10-05",{"date":115,"type":116},"2026-10-08","ACTUAL",{"date":118,"type":97},"2026-09",{"date":120,"type":97},"2031-09",{"name":5,"class":6},2]