The Baby Duchenne Study: Characterizing Developmental and Clinical Outcomes in the First Three Years in Children With Duchenne Muscular Dystrophy

Part of paid clinical trials in Rochester, New York.

Sponsor
University of Rochester
Study ID
NCT07092540
Status
Recruiting
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Conditions

  • Duchenne Muscular Dystrophy (DMD)

Eligibility Criteria

Sex
MALE
Age
0 Days - 3 Years
Healthy Volunteers
Not accepted

Study Details

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.

Key Dates

Start date
May 30, 2026
Status verified
Apr 2026
Primary completion
Aug 31, 2029
Completion
Aug 31, 2029

Study Design

Enrollment
105 participants (estimated)

Arms

  • Arm: Boys (0-3) of age diagnosed with DMD via new born screening

Primary Outcome Measure

Mean Change in Bayley Scales of Infant and Toddler Development, Fourth Edition (Bayley-4) Gross Motor Standard Score [ Time Frame: Baseline to 36 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of RochesterRochesterNew York14618-

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By research site
University of Rochester· Rochester, NY

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