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Very Low Birth Weight InfantNCT03034785

Flexible Electronics for Early Assessment

A study testing FlexiMitt in people with Very Low Birth Weight Infant, run by Wyss Institute at Harvard University at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 13 to 60 monthsHealthy volunteers can take part
Conditions the study is for
Very Low Birth Weight Infant
What is being tested?
FlexiMitt
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
33 participants
Where
2 sitesUnited States
Study dates
2 Aug 2017to 4 May 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 13 to 60 months
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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
Show all 28Show fewer
  • 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)

Who cannot join

  • 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 locations and contacts

2 sites in 1 country.

United States2 sites

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02115

  • Wyss Institute for Biologically Inspired Engineering at Harvard University

    Boston, Massachusetts, 02115

Other trials in United States

About this study

Official title: Young Hands at Work and Play: Flexible Electronics for Early Assessment of Force Modulation and Planning in Children Born Prematurely

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.

Being tested
FlexiMitt

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FlexiMittDevice

    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.

Study groups in NCT03034785
Study groupRoleWhat they receive
Group 1No interventionTerm
Group 2No interventionPreterm
Group 3ExperimentalTerm
Receives: Device: FlexiMitt
Group 4ExperimentalPreterm
Receives: Device: FlexiMitt

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Design and Fabricate FlexiMitts

    To measure joint angles and force

    Measured: Anticipated Year 1

  2. Demonstrate Safety

    Bench tests of material failure (i.e., stretch deformity and compositional integrity)

    Measured: Anticipated Year 1

  3. Examine group differences between Groups 1 and 2

    To examine group differences in force modulation and joint angles

    Measured: Anticipated Year 2 through 4

  4. Examine longitudinal differences between Groups 1 and 2

    To examine longitudinal changes in force modulation and joint angles at 24 and 30 months

    Measured: Anticipated Year 2 through 4

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2017 (estimated)
  2. Study start2 Aug 2017
  3. Primary completion4 May 2021
  4. Study completion4 May 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Device feasibility
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
33 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03034785
Sponsor's protocol ID
LCD-CS-0001
Other IDs
1R01HD090985-01, IRB16-1008
Status last verified
May 2020
First submitted
17 Jan 2017
Last updated
3 May 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
Yes

Publications

  • Lawn JE, Kinney M. Preterm birth: now the leading cause of child death worldwide. Sci Transl Med. 2014 Nov 19;6(263):263ed21. doi: 10.1126/scitranslmed.aaa2563. No abstract available.

    PubMed 25411468

  • Rubens CE, Sadovsky Y, Muglia L, Gravett MG, Lackritz E, Gravett C. Prevention of preterm birth: harnessing science to address the global epidemic. Sci Transl Med. 2014 Nov 12;6(262):262sr5. doi: 10.1126/scitranslmed.3009871.

    PubMed 25391484

  • Back SA. Cerebral white and gray matter injury in newborns: new insights into pathophysiology and management. Clin Perinatol. 2014 Mar;41(1):1-24. doi: 10.1016/j.clp.2013.11.001.

    PubMed 24524444

  • Gordon AM, Duff SV. Fingertip forces during object manipulation in children with hemiplegic cerebral palsy. I: anticipatory scaling. Dev Med Child Neurol. 1999 Mar;41(3):166-75. doi: 10.1017/s0012162299000353.

    PubMed 10210249

  • Stoll BJ, Hansen NI, Bell EF, Shankaran S, Laptook AR, Walsh MC, Hale EC, Newman NS, Schibler K, Carlo WA, Kennedy KA, Poindexter BB, Finer NN, Ehrenkranz RA, Duara S, Sanchez PJ, O'Shea TM, Goldberg RN, Van Meurs KP, Faix RG, Phelps DL, Frantz ID 3rd, Watterberg KL, Saha S, Das A, Higgins RD; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Neonatal outcomes of extremely preterm infants from the NICHD Neonatal Research Network. Pediatrics. 2010 Sep;126(3):443-56. doi: 10.1542/peds.2009-2959. Epub 2010 Aug 23.

    PubMed 20732945

  • Nordstrand L, Holmefur M, Kits A, Eliasson AC. Improvements in bimanual hand function after baby-CIMT in two-year old children with unilateral cerebral palsy: A retrospective study. Res Dev Disabil. 2015 Jun-Jul;41-42:86-93. doi: 10.1016/j.ridd.2015.05.003. Epub 2015 Jun 19.

    PubMed 26100242

  • Ulrich BD. Opportunities for early intervention based on theory, basic neuroscience, and clinical science. Phys Ther. 2010 Dec;90(12):1868-80. doi: 10.2522/ptj.20100040. Epub 2010 Oct 21.

    PubMed 20966210

  • Adolph KE, Berger SE, Leo AJ. Developmental continuity? Crawling, cruising, and walking. Dev Sci. 2011 Mar;14(2):306-18. doi: 10.1111/j.1467-7687.2010.00981.x.

    PubMed 21399716

  • 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

  • Slota GP, Latash ML, Zatsiorsky VM. Grip forces during object manipulation: experiment, mathematical model, and validation. Exp Brain Res. 2011 Aug;213(1):125-39. doi: 10.1007/s00221-011-2784-y. Epub 2011 Jul 7.

    PubMed 21735245

  • Santello M, Baud-Bovy G, Jorntell H. Neural bases of hand synergies. Front Comput Neurosci. 2013 Apr 8;7:23. doi: 10.3389/fncom.2013.00023. eCollection 2013.

    PubMed 23579545

  • Eliasson AC, Gordon AM, Forssberg H. Basic co-ordination of manipulative forces of children with cerebral palsy. Dev Med Child Neurol. 1991 Aug;33(8):661-70. doi: 10.1111/j.1469-8749.1991.tb14943.x.

    PubMed 1916022

  • Forssberg H, Eliasson AC, Kinoshita H, Johansson RS, Westling G. Development of human precision grip. I: Basic coordination of force. Exp Brain Res. 1991;85(2):451-7. doi: 10.1007/BF00229422.

    PubMed 1893993

  • Yoshikawa T, Nagai K. Manipulating and grasping forces in manipulation by multifingered robot hands. IEEE Transactions on Robotics and Automation 7:67-77, 1991.

Questions about this trial

What is this clinical trial studying?

A study testing FlexiMitt in people with Very Low Birth Weight Infant, run by Wyss Institute at Harvard University at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 28 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Design and Fabricate FlexiMitts (time frame: Anticipated Year 1). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03034785, which also lists 24 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2022.

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