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NCT06970522Recruiting

Wearable Sensors to Detect Atypical Muscle Activation in Young Infants

Shirley Ryan AbilityLab

Start Date

6/25/2025

Completion Date

12/31/2026

Summary

The purpose of this study is to see if wearable sensor technology can be used to evaluate muscle activity and/or identify atypical muscle tone in infants up to 48 weeks postmenstrual age (8 weeks corrected age). These sensors are placed on the surface of the skin and record data about a child's body movements and muscle activity.

Eligibility Criteria

Age Range: No minimum to No maximum

Inclusion Criteria: * For Infants with low tone: * Hospitalized in the NICU * AND \>38 weeks post-menstrual age * AND abnormal normal brain imaging OR Apgar score \<7 at five minutes with umbilical cord pH (if obtained) \<7.15 * AND 2 or more warning signs for muscle tone or posture using the HNNE short form * AND legal guardian able and willing to give written consent and comply with study procedures * For Infants with typical tone: * Born at 38-41 weeks of gestation * AND hospitalized after birth in the NICU OR well newborn nursery * AND infants with appropriate for gestational age birth weight * AND HNNE exam (short proforma) normal with no warning signs for any parameter * AND legal guardian able and willing to give written consent and comply with study procedures. Exclusion Criteria: * Infants of Both Low Tone and Typical Tone Cohorts: * Missing or incomplete limbs (such as from amputation or congenital limb defects). * Open wounds or skin breakdown on the limbs or torso. * Presence of known genetic syndrome or congenital anomalies requiring surgery or affecting function * Use of sedative medications (may include phenobarbital if level stable and therapeutic) * Legal guardian unable to give written consent and comply with study procedures. * Does not receive medical clearance from a physician to participate in the study if the individual is receiving inpatient care.

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Conditions

Neuromuscular DisordersMotor DevelopmentMuscle Tone

Locations

Ann & Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois 60611

United States

Shirley Ryan AbilityLab

Chicago, Illinois 60611

United States