Back to resultsFlexible Electronics for Early Assessment
Primary Purpose
Very Low Birth Weight Infant
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
FlexiMitt
Sponsored by
About this trial
This is an interventional device feasibility trial for Very Low Birth Weight Infant
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
Sites / Locations
- Beth Israel Deaconess Medical Center
- Wyss Institute for Biologically Inspired Engineering at Harvard University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
No Intervention
No Intervention
Experimental
Experimental
Arm Label
Group 1
Group 2
Group 3
Group 4
Arm Description
Term
Preterm
Term
Preterm
Outcomes
Primary Outcome Measures
Design and Fabricate FlexiMitts
To measure joint angles and force
Demonstrate Safety
Bench tests of material failure (i.e., stretch deformity and compositional integrity)
Examine group differences between Groups 1 and 2
To examine group differences in force modulation and joint angles
Examine longitudinal differences between Groups 1 and 2
To examine longitudinal changes in force modulation and joint angles at 24 and 30 months
Secondary Outcome Measures
Full Information
NCT ID
NCT03034785
First Posted
January 17, 2017
Last Updated
April 29, 2022
Sponsor
Wyss Institute at Harvard University
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Beth Israel Deaconess Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT03034785
Brief Title
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
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
August 2, 2017 (Actual)
Primary Completion Date
May 4, 2021 (Actual)
Study Completion Date
May 4, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wyss Institute at Harvard University
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Beth Israel Deaconess Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Very Low Birth Weight Infant
7. Study Design
Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
33 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1
Arm Type
No Intervention
Arm Description
Term
Arm Title
Group 2
Arm Type
No Intervention
Arm Description
Preterm
Arm Title
Group 3
Arm Type
Experimental
Arm Description
Term
Arm Title
Group 4
Arm Type
Experimental
Arm Description
Preterm
Intervention Type
Device
Intervention Name(s)
FlexiMitt
Intervention Description
The proposed research designs and fabricates 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.
Primary Outcome Measure Information:
Title
Design and Fabricate FlexiMitts
Description
To measure joint angles and force
Time Frame
Anticipated Year 1
Title
Demonstrate Safety
Description
Bench tests of material failure (i.e., stretch deformity and compositional integrity)
Time Frame
Anticipated Year 1
Title
Examine group differences between Groups 1 and 2
Description
To examine group differences in force modulation and joint angles
Time Frame
Anticipated Year 2 through 4
Title
Examine longitudinal differences between Groups 1 and 2
Description
To examine longitudinal changes in force modulation and joint angles at 24 and 30 months
Time Frame
Anticipated Year 2 through 4
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Months
Maximum Age & Unit of Time
60 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eugene Goldfield, Ph.D.
Organizational Affiliation
Wyss Institute for Biologically Inspired Engineering
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Wyss Institute for Biologically Inspired Engineering at Harvard University
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
12. IPD Sharing Statement
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Flexible Electronics for Early Assessment
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