Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Recruiting study of Klinefelter Syndrome and Trisomy X, sponsored by University of Colorado, Denver.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Cognitive skills will be assessed using the standardized Bayley Scales of Infant Development--3rd Edition (Bayley-3)
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 300 participants |
| Start Date | 2017-09-29 |
| Est. Completion | 2028-03-01 |
What NCT03396562 shows while recruiting
NCT03396562 is an observational study that tracks outcomes without assigning an intervention. The registered 300 participants enrollment target is mid-sized for trials with a published cap, above the 214-participant average among 4 other Klinefelter Syndrome trials with a reported enrollment target (40% higher).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Klinefelter Syndrome
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
Interrogating Fatty Acid Metabolism Impairment and Clinical Correlates in Males with Klinefelter Syndrome
ACTIVE NOT RECRUITING · Phase 4
-
Body Composition in Infants With Klinefelter Syndrome and Effects of Testosterone Treatment
COMPLETED · Phase 4
-
Cardiometabolic Profiles of Boys With Klinefelter Syndrome
COMPLETED
-
Expanded Noninvasive Genomic Medical Assessment: The Enigma Study
COMPLETED
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00353483 · 300 participants
Effect of Neoadjuvant or Adjuvant Systemic Therapy on Breast Cancers, Bone Marrow Cancer Cells, and Circulating Cancer Cells
- NCT00588185 · 300 participants · NA
[18F]-Fluoro-2-Deoxy-D-Glucose and -[18F] Dihydro-Testosterone Pet Imaging in Patients With Progressive Prostate Cancer
- NCT00682032 · 300 participants · NA
The Effect of Beta-glucan in Non-Small Cell Lung Cancer
- NCT00870064 · 300 participants · NA
The Treatment of Type I Open Fractures in Pediatrics
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI