Automated assessment of neurodevelopment in infants at risk for motor disability
This study is testing new technology to see if it can help doctors spot movement delays in babies at risk for motor disabilities so they can get the right help sooner.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1700 (estimated) |
| Ages | 0 Months to 6 Months |
| Sex | All |
| Sponsor | University of Pennsylvania Academic / other |
| Locations | 1 site (Philadelphia, Pennsylvania) |
| Trial ID | NCT04321200 on ClinicalTrials.gov |
What this trial studies
This study aims to improve early detection of motor delays in infants by utilizing advanced sensors and machine learning algorithms. It focuses on developing objective and easy-to-use tools for scoring neurodevelopmental deficits, which can lead to timely interventions. By analyzing video and sensor data from infants in a specially designed gym, the study seeks to correlate movement patterns with existing clinical measures. The goal is to create a new generation of assessments that are both accurate and user-friendly for healthcare providers.
Who should consider this trial
Good fit: Ideal candidates for this study are infants aged 0-6 months, including those with early brain injuries or those classified as moderate risk due to preterm birth or other medical issues.
Not a fit: Patients who are older than 6 months at the time of enrollment or those without any risk factors for neurodevelopmental disabilities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to earlier and more accurate interventions for infants at risk of motor disabilities, improving their long-term health outcomes.
How similar studies have performed: Other studies have shown promise in using technology and machine learning for early detection of developmental delays, but this specific approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Infants, male and female, between 0-6 months (Infants older than 6 months before initial enrollment will be excluded). * Infants with early brain injury (EBI): * Hydrocephalus * Hypoxic-ischemic encephalopathy (HIE) * Periventricular leukomalacia (PVL) * Intraventricular hemorrhage (IVH) * Stroke * Healthy infants (controls): o No history of early brain injury (EBI) * Infants without EBI/risk for future disability: * Infants without known brain injuries, but with a history of preterm birth less than 32-week gestation with significant medical problems, difficulty eating, or who lack head control at 4 months of age or later will be classified as moderate risk.
Where this trial is running
Philadelphia, Pennsylvania
- Childrens Hospital of Philadelphia — Philadelphia, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Michelle J Johnson, PhD — The University of Pennsylvania
- Study coordinator: Michelle J Johnson, PhD
- Email: johnmic@pennmedicine.upenn.edu
- Phone: 215-893-2665
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.