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Trial record 6 of 24 for:    Recruiting, Not yet recruiting, Available Studies | "Infant, Low Birth Weight"

Flexible Electronics for Early Assessment

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ClinicalTrials.gov Identifier: NCT03034785
Recruitment Status : Recruiting
First Posted : January 27, 2017
Last Update Posted : June 26, 2018
Sponsor:
Collaborators:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Beth Israel Deaconess Medical Center
Information provided by (Responsible Party):
Eugene Goldfield, Wyss Institute at Harvard University

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. Additionally, the investigators plan to have the parent/guardian wear the gloves so they can determine the relative contributions of the child and the adult to the child's learning. In the same way that the adult assists learning to walk, they may assist in learning during play. The force data may be analyzed in the same way as the child's data.

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.


Condition or disease Intervention/treatment Phase
Very Low Birth Weight Infant Device: FlexiMitt Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Young Hands at Work and Play: Flexible Electronics for Early Assessment of Force Modulation and Planning in Children Born Prematurely
Actual Study Start Date : August 2, 2017
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : January 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birth Weight

Arm Intervention/treatment
Experimental: Group 1
Very low birth weight infants
Device: FlexiMitt
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.

Active Comparator: Group 2
Healthy infants
Device: FlexiMitt
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 Measures :
  1. Design and Fabricate FlexiMitts [ Time Frame: Anticipated Year 1 ]
    To measure joint angles and force

  2. Demonstrate Safety [ Time Frame: Anticipated Year 1 ]
    Bench tests of material failure (i.e., stretch deformity and compositional integrity)

  3. Examine group differences between Groups 1 and 2 [ Time Frame: Anticipated Year 2 through 4 ]
    To examine group differences in force modulation and joint angles

  4. Examine longitudinal differences between Groups 1 and 2 [ Time Frame: Anticipated Year 2 through 4 ]
    To examine longitudinal changes in force modulation and joint angles at 18, 24, and 30 months



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Ages Eligible for Study:   13 Months to 60 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Very Low Birth Weight (VLBW) Infants 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 participate in testing
  • Otherwise healthy condition

VLBW Infants Longitudinal Study:

  • Ages 13-60 months (with the target age around 18 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 participate in testing
  • Otherwise healthy condition

Healthy Infants 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 participate in testing

Healthy Infants Longitudinal Study:

  • Ages 13-60 months (with the target age around 18 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 participate in testing

Parent/Guardian

• Must be a parent/guardian of child in Group 1 or Group 2

Exclusion Criteria:

Both Healthy and VLBW Infants

  • 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 participate

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03034785


Contacts
Contact: Eugene Goldfield, Ph.D. 617-355-8353 Eugene.goldfield@childens.harvard.edu
Contact: Dionna O Williams, MS, MPH 617-432-1578 dionna.williams@wyss.harvard.edu

Locations
United States, Massachusetts
Beth Israel Deaconess Medical Center Not yet recruiting
Boston, Massachusetts, United States, 02115
Contact: Vincent C Smith, M.D.    617-667-3276    vsmith1@bidmc.harvard.edu   
Wyss Institute for Biologically Inspired Engineering at Harvard University Recruiting
Boston, Massachusetts, United States, 02115
Contact: Eugene Goldfield, Ph.D.    617-355-8353    Eugene.Goldfield@childrens.harvard.edu   
Sponsors and Collaborators
Wyss Institute at Harvard University
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Beth Israel Deaconess Medical Center

Publications:
Goldfield EC, Wolff PH. A dynamical systems perspective on infant action and it's development. Oxford Wiley-Blackwell; 2004
Thelen E, Smith L. A dynamic systems approach to the development of cognition and action. Cambridge, MA: MIT Press 1994
Yoshikawa T, Nagai K. Manipulating and grasping forces in manipulation by multifingered robot hands. IEEE Transactions on Robotics and Automation 7:67-77, 1991.
Park WL, Chen BR, Wood RJ. Design and fabrication of soft artificial skin using embedded micro channels and liquid conductors. IEEE Sensors Journal 12(8):2711-2718, 2012.
Park YL, Majidi C, Kramer R, Berard P, Wood RJ. Hyperelastic pressure sensing with a liquid-embedded elastomer. Journal of Micromechanics and Microengineering 20(12), 2010.
Majidi C, Kramer R, Wood RJ. A non-differential elastomer curvature sensor for softer-than-skin electronics. Smart Materials and Structures 20(10), 2011
Vogt D, Park YL, Wood RJ. Design and characterization of a soft multi-axis force sensor using embedded microfluidic channels. IEEE Sensors Journal 13(10):4056-4064, 2013
Endo Y, Tada M, Mochimaru M. Dhaiba: Development of Virtual Ergonomic Assessment System with Human Models Digital Human Modeling 1-8, 2014.
Benjamini Y, Hochberg Y. Controlling the false discovery rate: A practical and powerful approach to multiple testing. Journal of the Royal Statistical Society Series B (Methodological) 57(1):289-300, 1995.
Diggle P, Liang K-Y, Zeger SL. Analysis of longitudinal data. Clarendon Press; 1994.

Responsible Party: Eugene Goldfield, Associate Professor of Psychology in Psychiatry, Wyss Institute at Harvard University
ClinicalTrials.gov Identifier: NCT03034785     History of Changes
Other Study ID Numbers: LCD-CS-0001
1R01HD090985-01 ( U.S. NIH Grant/Contract )
IRB16-1008 ( Other Identifier: Harvard Longwood Medical Area IRB )
First Posted: January 27, 2017    Key Record Dates
Last Update Posted: June 26, 2018
Last Verified: June 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Birth Weight
Body Weight
Signs and Symptoms