An interventional study of PUMA in Down Syndrome, sponsored by Boston University Charles River Campus. Not yet recruiting at 1 site in United States. Open to participants aged 6 Months to 24 Months. Per ClinicalTrials.gov, last updated 2026-11-13.
Sponsored by Boston University Charles River Campus · Not applicable, Interventional, and Supportive care
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Among 205 studies in Down Syndrome with a site in United States — 48 open to participants now, 56 under way, 4 of them phase 3. Down Syndrome · United States.
Among the 205 studies in Down Syndrome with a site in United States, this one is the 40th largest by planned enrollment of the 131 interventional ones that give a count, is the only one that started in 2027, is one of 82 with no phase, reaches primary completion later than 46 of the 55 other live ones, and was the 205th registered.
439 studies on the registry are indexed under Down Syndrome; 100 are open to participants now.
Browse Down Syndrome studies →48 of the 205 studies in Down Syndrome with a site in United States are open now. Recruiting first, the newest first:
Alnylam Pharmaceuticals · Sites in United States, Spain
Ages 40–55
Ohio State University · Sites in United States
Ages 5–12
National Institute of Allergy and Infectious Diseases (NIAID) · Sites in United States
Ages 1–120 · Healthy volunteers
University of Colorado, Denver · Sites in United States
Ages 6–22
RTI International · Sites in United States
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 75 Down Syndrome studies recruiting now, 14 (19%) set no upper age limit and 58 (77%) stop at 75 or younger; 61 take children under 18; 19 take healthy volunteers.
This study: 6 Months to 24 Months · all sexes · no healthy volunteers.
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205 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 11 · Phase 2 26 · Phase 3 10 · Phase 4 5
First in 1981; this study’s year is marked. 1 started in 2027.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 60 is above the median of 38 across 287 interventional studies indexed under Down Syndrome.
Median enrollment 40 across the 131 interventional studies, 433 across the 74 observational. Of the 139 that completed or were terminated, 42 (30%) have results posted.
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47 of 205 have an industry lead sponsor. The 10 most frequent:
Boston University Charles River Campus is the lead sponsor of 160 studies on the registry; 34 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 11 (79%) have results posted.
Boston University Charles River Campus has 3 studies filed under Down Syndrome — fewer than ten, so there is no comparison to draw.
14 of the studies in Down Syndrome with a site in United States that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT03914625Phase 3National Cancer Institute (NCI)A Study to Investigate Blinatumomab in Combination With Chemotherapy in Patients With Newly Diagnosed B-Lymphoblastic Leukemia | 2027-09-30 |
| NCT04278404Duke UniversityPharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children Per Standard of Care (POPS) | 2026-11 |
| NCT07008989Boston CollegeA VIRTUAL Three-month Intervention Study of the Effects of a Smartphone Application (HippoCamera) on Memory in Teens and Young Adults With Down Syndrome | 2026-12-31 |
| NCT05196984Massachusetts Institute of TechnologyGamma Frequency Stimulation in Individuals With Down Syndrome | 2026-12-31 |
| NCT03233646Duke UniversityRetinal Imaging in Neurodegenerative Disease | 2026-12-31 |
Add all 14 to your calendar (.ics) → With an account.
Among the 205 studies in Down Syndrome with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
Infants with Down syndrome (DS) exhibit early developmental delays in motor skills and multiple other domains. Once infants are upright and moving, they have new opportunities for exploring the environment and interacting with objects and people that are important for early learning and development. This project will allow the investigators to assess the feasibility of a home-based mobility and play intervention for infants with DS (using a body weight supported harness system- Portable Mobility Use Aid (PUMA) for Children and characterize its impact on promoting mobility, exploration, and play with objects and caregivers. PUMA is a specialized pediatric partial body-weight support system designed to give children with developmental delays or physical disabilities the upright support they need to move, explore, and play independently.
Inclusion Criteria:
Infants/toddlers inclusion criteria
Primary caregiver inclusion criteria
Infants/toddlers exclusion criteria:
The investigators will deliver a Portable Mobility Use Aid (PUMA) system for Children playtime to the home and assist caregivers with setup.
Other: PUMA
Families will be asked to use the PUMA system with their infant 5 days/week for a minimum of 30 min (longer is permitted) for one month.
Infant upright postures
This outcome will be assessed by the proportion of time the infant spends in an upright posture
Time frame: baseline, 2 weeks, 1 month, 6 months, 12 months
Infant locomotion
This outcome will be assessed by the proportion of time the infant spends in locomotion
Time frame: baseline, 2 weeks, 1 month, 6 months, 12 months
Infant initiated proximity changes
This outcome will be assessed by the proportion of Infant initiated proximity changes
Time frame: baseline, 2 weeks, 1 month, 6 months, 12 months
Joint object play bouts
This outcome will be assessed by the proportion of joint object play bouts
Time frame: baseline, 2 weeks, 1 month, 6 months, 12 months
Infant-initiated proximity
This outcome will be assessed by the proportion of infant-initiated proximity
Time frame: baseline, 2 weeks, 1 month, 6 months, 12 months
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Jan 2027; primary completion for Jan 2030, 36 months later.
Of 163 non-industry interventional studies with no phase under Down Syndrome, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 33. This study's planned 36 months is above that.
Counting every sponsor, half of 165 studies reached it within 11 months; a quarter within 3 and three quarters within 35.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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Boston University Charles River Campus →