Clinical trial NCT03034785: Flexible Electronics for Early Assessment
Official title: Young Hands at Work and Play: Flexible Electronics for Early Assessment of Force Modulation and Planning in Children Born Prematurely
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Very Low Birth Weight Infant
Lead sponsor: Wyss Institute at Harvard University
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: Beth Israel Deaconess Medical Center
First posted: 2017-01-27
Enrollment: 33
Sex: ALL
Minimum age (years): 13
Maximum age (years): 60
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DEVICE_FEASIBILITY

Brief summary: The morbidities associated with very low birth weight (VLBW) infants constitute a major health problem and a significant emotional and financial burden for families and our nation. The key to reducing this burden is early diagnosis. This research will be the first step towards intervention for cerebral growth and long-term neurodevelopmental morbidities of VLBW infants.

The proposed research is to design and fabricate a new technological innovation in wearable soft-sensors, called flexi-mitts, for measuring force modulation and joint angles of the hand (wrist and fingers) of toddlers. Building upon the investigators' ongoing work, they plan to engineer stretchable electronics for safe, toddler-scaled flexi-mitts to measure planning and force modulation.

The investigators' new flexi-mitt technology has the potential to provide a new diagnostic technology and the development of clinical assessment norms. With additional trials of the technology in large numbers of young children, it may be possible for clinicians and day care providers to eventually make measurements of planning and force modulation in play settings.


Eligibility criteria: Inclusion Criteria:

Children Born Prematurely ("Preterm") -

Pilot Studies:

* Ages 13-60 months (with the target ages around 18, 24, and 30 months)
* Very low birth weight (less than 1500 grams)
* Born between 28 and 33 weeks
* Parent/Legal guardian provides written consent
* Parent/Legal guardian is willing to facilitate testing with child (and may be included in photos/videos as a result)
* Otherwise healthy condition

Longitudinal Study:

* Ages 13-60 months (with the target age around 24 months) at the time of enrollment
* Very low birth weight (less than 1500 grams)
* Born between 28 and 33 weeks
* Parent/Legal guardian provides written consent
* Parent/Legal guardian is willing to facilitate testing with child (and may be included in photos/videos as a result)
* Otherwise healthy condition

Typically Developing Children ("Term") -

Pilot Studies:

* Ages 13-60 months (with the target ages around 18, 24, and 30 months)
* Born at full term (37 weeks or later)
* Healthy, with no history of neurological problems or musculoskeletal disorders, self-reported by parent or legal guardian
* Parent/Legal guardian provides written consent
* Parent/Legal guardian is willing to facilitate testing with child (and may be included in photos/videos as a result)

Longitudinal Study:

* Ages 13-60 months (with the target age around 24 months) at time of enrollment
* Born at full term (37 weeks or later)
* Healthy, with no history of neurological problems or musculoskeletal disorders, self-reported by parent or legal guardian
* Parent/Legal guardian provides written consent
* Parent/Legal guardian is willing to facilitate testing with child (and may be included in photos/videos as a result)

Exclusion Criteria:

Both Preterm and Term

* Child has a history of/or currently exhibits any severe neurological complications, such as perinatal intraventricular hemorrhage (Grade 3 or 4) or periventricular leukomalacia
* The participant is a child of a PI or other IRB-approved study team member
* Parent/legal guardian does not provide consent or is unwilling to facilitate testing with child

Primary outcomes:
measure: Design and Fabricate FlexiMitts
timeFrame: Anticipated Year 1
measure: Demonstrate Safety
timeFrame: Anticipated Year 1
measure: Examine group differences between Groups 1 and 2
timeFrame: Anticipated Year 2 through 4
measure: Examine longitudinal differences between Groups 1 and 2
timeFrame: Anticipated Year 2 through 4
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Wyss Institute for Biologically Inspired Engineering at Harvard University
state: Massachusetts
Study officials:
affiliation: Wyss Institute for Biologically Inspired Engineering
name: Eugene Goldfield, Ph.D.
role: PRINCIPAL_INVESTIGATOR
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