eXtroardinarY Babies Study: Health and Neurodevelopment in Infants with Sex Chromosome Trisomy

This observational study, called the eXtroardinarY Babies Study, is looking at the natural development and health of infants and young children with certain sex chromosome variations, such as Klinefelter Syndrome (XXY), Trisomy X (XXX), and XYY Syndrome. Researchers want to understand how these conditions affect development, health, and early hormone function. They will also evaluate different developmental screening tools to help pediatricians better care for children with these conditions. You might be able to join if you have an infant between 6 weeks and 13 months old with a prenatal diagnosis of a sex chromosome variation that is confirmed after birth, and you speak English or Spanish. The study will measure cognitive, motor, and language scores using the Bayley-III assessment at 36 months of age to understand developmental progress.

Study design
This is an observational study planning to enroll 300 participants. It is not testing a specific drug or treatment.
What's involved
Participants will have longitudinal observational assessments of development and growth at various ages, from 2 months up to 9 years old.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed until at least 9 years of age, with primary endpoints measured at 36 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT03396562

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

Recruiting
Not specifiedAges 6–13Observational
University of Colorado, Denver
~300 participants
Updated 2024-05-09 on ClinicalTrials.gov
What's tested:Assessments of Development and Growth

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Longitudinal Descriptive Statistics of Cognitive Scores on the Bayley-III
Measured over 36 months
+2 more outcomes measured
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

NCT03396562

Where you'd take part

This study runs at 2 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Children's Hospital Colorado

    Aurora, Coloradostudy coordinator listed

    Recruiting

  • Nemours at Thomas Jefferson University

    Philadelphia, Pennsylvaniastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

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

Opens a ready-to-send draft in your own email app — review before sending.

  • Longitudinal Descriptive Statistics of Cognitive Scores on the Bayley-III36 months

    Cognitive skills will be assessed using the standardized Bayley Scales of Infant Development--3rd Edition (Bayley-3)

  • Longitudinal Descriptive Statistics of Motor Scores on the Bayley-III36 months

    Motor development will be assessed using the standardized Bayley Scales of Infant Development--3rd Edition (Bayley-3)

  • Longitudinal Descriptive Statistics of Language Scores on Bayley-III36 months

    Language development will be assessed using the Bayley Scales of Infant Development--3rd Edition (Bayley-3)