About this trial
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.
The 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.
The main benefit of being in this study is to help monitor the participating child's motor development.
The 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
BW <1500 grams OR
Disorders of the central nervous system
Brain injury (including but not limited to extra axial hemorrhage, any grade intraventricular or intraparenchymal hemorrhage, stroke, hypoxic ischemic encephalopathy (HIE), meningitis)
HIE includes mild, moderate, severe exam on modified Sarnat exam, both cooled and non-cooled
Disqualifiers
Open wounds, skin condition precluding sensor placement
Immune deficiencies requiring protective isolation
Limb reduction defects
Followed primarily in another clinic (including but not limited to meningomyelocele and related conditions/trisomy 21)
Trial population
infants who are at risk of motor or other developmental delay
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
3-month Screening Performance (Aims 1-2, Toolkit Development cohort)
Screening performance of the toolkit at 3 months (internal validation)
3-month Screening Performance (Aim 3; Toolkit Validation cohort)
Screening performance of the toolkit at 3 months (external validation)
Secondary outcomes
12-month Screening Performance (Aims 1-2; Toolkit Development cohort)
Screening performance of the toolkit at 12 months (internal validation)
12-month Screening Performance (Aim 3; Toolkit Validation cohort)
Screening performance of the toolkit at 12 months (external validation)
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Shirley Ryan AbilityLab
Lead sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
University of Illinois at Chicago
Collaborator
This trial is not recruiting at the moment. You can still explore other options: