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

NCT03396562 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 300

Last updated 2024-05-09

No results posted yet for this study

Summary

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.

Conditions

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

Interventions

OTHER

Assessments of Development and Growth

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.

Sponsors & Collaborators

  • University of Colorado, Denver

    lead OTHER

Principal Investigators

  • Nicole Tartaglia, MD MS · University of Colorado, Denver

Eligibility

Min Age
6 Weeks
Max Age
13 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-29
Primary Completion
2028-03-01
Completion
2028-03-01

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03396562 on ClinicalTrials.gov