NCT07092540Recruiting
The Baby Duchenne Study: Characterizing Developmental and Clinical Outcomes in the First Three Years in Children With Duchenne Muscular Dystrophy
Source: ClinicalTrials.gov · Last updated 19 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 105 (estimated)
- First submitted
- 22 Jul 2025
- Start date
- 3 Jun 2026
- Primary completion date
- 31 Aug 2029
- Lead sponsor
- University of Rochester
- Diseases
- Duchenne muscular dystrophy
- NCT number
- NCT07092540
What you commit to
- Study type: Observational
- Planned participants: 105
- From 3 Jun 2026 to the primary completion date, 31 Aug 2029
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Other
- Female
- Inability/unwillingness of parent/guardian to provide written permission (sign PPF) or to comply with the protocol Schedule of Activities.
Who the study is looking for
- 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.
Age in the registry: 0 days to 3 years · Sex: Male · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cincinnati Children's Hospital Medical Center Coordinator of this site? Confirm its status | Cincinnati | United States | Not yet recruiting |
| Nationwide Children's Hospital Coordinator of this site? Confirm its status | Columbus | United States | Recruiting |
| University of Rochester Coordinator of this site? Confirm its status | Rochester | United States | Recruiting |
| Stony Brook Medicine Coordinator of this site? Confirm its status | Stony Brook | United States | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.