The eXtroardinarY Babies Study: Natural History of Health and Neurodevelopment in Infants and Young Children With Sex Chromosome Trisomy

Part of paid clinical trials in Aurora, Colorado.

Sponsor
University of Colorado, Denver
Study ID
NCT03396562
Status
Recruiting
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Conditions

  • Klinefelter Syndrome
  • Male With Sex Chromosome Mosaicism
  • Trisomy X
  • XXXY and XXXXY Syndrome
  • XYY Syndrome
  • Xxxx Syndrome
  • Xxxxx Syndrome
  • Xxxyy Syndrome
  • Xxyy Syndrome
  • Xxyyy Syndrome
  • Xyyy Syndrome
  • Xyyyy Syndrome

Eligibility Criteria

Sex
ALL
Age
6 Weeks - 13 Months
Healthy Volunteers
Not accepted

Interventions

  • Assessments of Development and Growth — OTHER
    Longitudinal observational assessments of development and growth at ages: 2 months, 6 months, 12 months, 18 months, 24 months, 36 months, 48 months, 5 years, 6 years, 7 years, 8 years, 9 years of age.

Study Details

This study is designed to research the natural history of neurodevelopment, health and early hormonal function in infants with XXY/Klinefelter syndrome, XYY, XXX and other sex chromosome variations in an effort to identify early predictors of developmental and health outcomes. The Investigators will also evaluate different developmental screening tools in infants with sex chromosome variations so the investigators can develop recommendations for pediatrician caring for infants and young children with XXY/Klinefelter syndrome, XYY, XXX, and other sex chromosome variations.

Key Dates

Start date
Sep 29, 2017
Status verified
May 2024
Primary completion
Mar 1, 2028
Completion
Mar 1, 2028

Study Design

Enrollment
300 participants (estimated)

Arms

  • Arm: SCT Conditions
    Sex Chromosome Trisomies Conditions including Klinefelter (XXY), Trisomy X (XXX), XXY Syndromes. Interventions: Longitudinal observational assessments of development and growth at ages: 2 months, 6 months, 12 months, 18 months, 24 months, 36 months, 48 months, and 5 or 6 years.

Primary Outcome Measure

Longitudinal Descriptive Statistics of Cognitive Scores on the Bayley-III [ Time Frame: 36 months ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Children's Hospital ColoradoAuroraColorado80045
Susan Howell, MS, CGC, MBA
[email protected]
720-777-8361
Mariah Brown
[email protected]
(720)777-6774
Nicole Tartaglia, MD MS (PRINCIPAL_INVESTIGATOR)
Shanlee Davis, MD MSCS (SUB_INVESTIGATOR)
Susan Howell, MS (SUB_INVESTIGATOR)
Rebecca Wilson, PsyD (SUB_INVESTIGATOR)
Jennifer Janusz, PsyD (SUB_INVESTIGATOR)
Laura Pyle, PhD (SUB_INVESTIGATOR)
Samantha Bothwell, MS (SUB_INVESTIGATOR)
Nemours at Thomas Jefferson UniversityPhiladelphiaPennsylvania19107
Judith Ross, MD
[email protected]
215-955-1648
Karen Kowal, PAC
[email protected]
215-9559008
Judith Ross, MD (PRINCIPAL_INVESTIGATOR)
Karen Kowal, PAC (SUB_INVESTIGATOR)
CJ Ikomi, MD (SUB_INVESTIGATOR)
Greg Lipkin, PhD (SUB_INVESTIGATOR)

Find similar trials in Aurora, CO

By research site
Children's Hospital Colorado· Aurora, CONemours at Thomas Jefferson University· Philadelphia, PA

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