Flexible Electronics for Early Assessment

Wyss Institute at Harvard University

Status: Completed

Conditions: Very Low Birth Weight Infant

Treatments: Device: FlexiMitt

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03034785

LCD-CS-0001

IRB16-1008 (Other Identifier)

1R01HD090985-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 33 patients

Sex: All

Ages: 13 to 60 months old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Device Feasibility

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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33 participants in 4 patient groups

Group 1

No Intervention group

Description:

Term

Group 2

No Intervention group

Description:

Preterm

Group 3

Experimental group

Description:

Term

Treatment:

Device: FlexiMitt

Group 4

Experimental group

Description:

Preterm

Treatment:

Device: FlexiMitt