Using wearable sensors to monitor muscle activity in infants

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to evaluate the effectiveness of wearable sensor technology in assessing muscle activity and identifying atypical muscle tone in infants up to 48 weeks postmenstrual age. The sensors are placed on the skin to record data on body movements and muscle activity, focusing on infants with both low and typical muscle tone. The study includes infants hospitalized in the NICU or well newborn nursery, and it seeks to gather data that could lead to early detection of neuromuscular disorders.

Why it matters

Who can join: the full rules

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.

Where it's running

• Ann & Robert H. Lurie Children's Hospital of Chicago
  Chicago, Illinois, United States Recruiting
• Shirley Ryan AbilityLab
  Chicago, Illinois, United States Recruiting

Study contacts

• Principal investigator: Arun Jayaraman, PT, PhD — Shirley Ryan AbilityLab
• Study coordinator: Rachel Andersen
• Email: randersen@sralab.org
• Phone: 312-238-1476

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.