NCT07092540 The Baby Duchenne Study: Characterizing Developmental and Clinical Outcomes in the First Three Years in Children With Duchenne Muscular Dystrophy
| NCT ID | NCT07092540 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Rochester |
| Condition | Duchenne Muscular Dystrophy (DMD) |
| Study Type | OBSERVATIONAL |
| Enrollment | 105 participants |
| Start Date | 2026-06-03 |
| Primary Completion | 2029-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 105 participants in total. It began in 2026-06-03 with a primary completion date of 2029-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The aim of the BABY DUCHENNE study is to evaluate the natural history and characterize the early clinical outcomes in very young children (0-3 years) with Duchenne muscular dystrophy (DMD) identified by newborn screening programs.
Eligibility Criteria
Inclusion Criteria: * Male child between birth and 3.0 years of age at time of enrollment. * A confirmed and documented pathogenic or likely pathogenic variant in the DMD gene. * Ability of parent/guardian to understand and provide written informed consent (signing Parental Permission and Consent Form). * Willingness of parent/guardian to comply with the protocol Schedule of Activities, including all study site visits. Exclusion Criteria: * Female * Presence of any confirmed genetic disease, other than DMD, that could impact early development, which, in the opinion of the PI, may confound interpretation of developmental progress. * Presence of any significant medical condition (i.e., extreme prematurity, hypoxic ischemic encephalopathy) which, in the opinion of the PI, may confound interpretation of the clinical course of DMD. * Inability/unwillingness of parent/guardian to provide written permission (sign PPF) or to comply with the protocol Schedule of Activities.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07092540 clinical trial?
This trial is open to male participants only, aged 0 Days or older, up to 3 Years, studying Duchenne Muscular Dystrophy (DMD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07092540 currently recruiting?
Yes, NCT07092540 is actively recruiting participants. Contact the research team at Kim_Hart@urmc.rochester.edu for enrollment information.
Where is the NCT07092540 trial being conducted?
This trial is being conducted at Rochester, United States, Stony Brook, United States, Cincinnati, United States, Columbus, United States.
Who is sponsoring the NCT07092540 clinical trial?
NCT07092540 is sponsored by University of Rochester. The trial plans to enroll 105 participants.