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NCT03396562 · ClinicalTrials.gov registry record

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

A clinical trial of Klinefelter Syndrome and Trisomy X, sponsored by University of Colorado, Denver.

Recruiting
Registry status
300
Enrollment target
2
Study locations

NCT03396562 is a study of Klinefelter Syndrome and Trisomy X that is actively recruiting participants, run by University of Colorado, Denver. The registered enrollment target is 300 participants, above the 214-participant average among 4 other Klinefelter Syndrome trials with a reported enrollment target (40% higher). The trial reports 2 study locations across 2 states.

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The verdict

NCT03396562, a study of Klinefelter Syndrome and Trisomy X, is actively recruiting participants, sponsored by University of Colorado, Denver.

RECRUITING
Registry status
300 participants
Enrollment target
2
Study locations

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 Studied

Klinefelter Syndrome Trisomy X XYY Syndrome XXXY and XXXXY Syndrome Xxyy Syndrome Xyyy Syndrome Xxxx Syndrome Xxxxx Syndrome Xxxyy Syndrome Xxyyy Syndrome

Interventions

  • OTHER Assessments of Development and Growth

Study Locations (2)

Colorado

  • Children's Hospital Colorado - Aurora

Pennsylvania

  • Nemours at Thomas Jefferson University - Philadelphia

Trial Details

FieldValue
Enrollment Target 300 participants
Start Date 2017-09-29
Est. Completion 2028-03-01

Sponsor

University of Colorado, Denver

1,283 total trials

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What the Registry Record Tells You About NCT03396562

The ClinicalTrials.gov registry entry for NCT03396562 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 300 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 214-participant average among 4 other Klinefelter Syndrome trials with a reported enrollment target (40% higher). The listed sponsor is University of Colorado, Denver, which has 1,283 total studies on file at ClinicalTrials.gov.

The record links to 10 conditions, with Klinefelter Syndrome appearing as the primary indexed condition, and to 1 intervention - of which Assessments of Development and Growth is the first listed.

NCT03396562 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Colorado, Pennsylvania.

Frequently Asked Questions

What is clinical trial NCT03396562 about?

NCT03396562 is a clinical study titled "The eXtroardinarY Babies Study: Natural History of Health and Neurodevelopment in Infants and Young Children With Sex Chromosome Trisomy". 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...

What is the current status of trial NCT03396562?

This trial is currently recruiting. The enrollment target is 300 participants. The study started on 2017-09-29. Estimated completion is 2028-03-01.

What conditions does trial NCT03396562 study?

This clinical trial studies the following conditions: Klinefelter Syndrome, Trisomy X, XYY Syndrome, XXXY and XXXXY Syndrome, Xxyy Syndrome.

What interventions are being tested in trial NCT03396562?

The interventions under investigation include: Assessments of Development and Growth (OTHER).

Who is sponsoring clinical trial NCT03396562?

This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03396562 being conducted?

This trial has 2 study locations across Colorado, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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