An observational study in Congenital Disorders, sponsored by Children's Healthcare of Atlanta. Terminated at 1 site in United States. Open to participants aged Up to 1 Year. Per ClinicalTrials.gov, last updated 2012-03-16.
Sponsored by Children's Healthcare of Atlanta · Observational
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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 61st largest by enrollment of the 74 observational ones that give a count, is one of 2 that started in 2001, is one of 74 observational ones, and was the 4th 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: Up to 1 Year · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
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. 2 started in 2001.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 46 is below the median of 158 across 145 observational 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:
Children's Healthcare of Atlanta is the lead sponsor of 97 studies on the registry; 6 are open to participants now.
Children's Healthcare of Atlanta has 2 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.
Failure to thrive and difficulty gaining weight is a sign of uncompensated congestive heart failure (CHF). Infants with Trisomy 21 and complete atrioventricular canal defects (CAVC) frequently develop uncompensated CHF and weight gain failure pre-operatively. A weight of 5 kg has been suggested as optimal for timing of CAVC repair. A delay in surgical repair often occurs if weight gain stalls and reaches a plateau prior to reaching 5 kg. A retrospective review performed by Kogon, et al, of children undergoing surgery for VSD at CHOA at Egleston recently reported that age and weight at surgery may not, however, be associated with adverse surgical outcome.
The purpose of this study is to determine the optimal timing for surgical correction of CAVC in Trisomy 21 infants based on reaching a plateau of failed weight gain despite maximal anti-congestive and nutritional therapy.
A retrospective chart review of 100 infants with Trisomy 21 and CAVC operated at CHOA at Egleston between January 1, 2001 and March 24, 2006 will be performed. Graphs of birth weight and rate of weight gain over time will be plotted for each patient and for the group as a whole. The point of reaching a plateau of weight gain will be decided for each patient and indexed for birth weight. Medical management will be detailed, i.e. all medications and all dietary information (caloric density of formula, route of administration). This medical management will be indexed as a function on the weight gain chart. Medical complications (such as respiratory infections, gastroenteritis, hospitalizations, and additional non-cardiac medications) will likewise be plotted and segmented according to position relative to the weight gain plateau. Age at eventual surgery and whether surgical date was delayed by complications will be noted. Surgical cardiopulmonary bypass time and morbidity and mortality will be noted. Postoperative length of ventilator support, length of stay in the CICU and total length of stay will be determined and also displayed as a function of body weight and as a function of time at plateau weight. Postoperative morbidity and mortality for the three months after repair will be noted, including all cause hospital re-admissions and outpatient medical complications (such as respiratory infections, gastroenteritis, and the need for continued medications for CHF).
439 studies on the registry are indexed under Down Syndrome; 100 are open to participants now.
This study's enrollment of 46 is below the median of 158 across 145 observational studies indexed under Down Syndrome.
Browse Down Syndrome studies →Children's Healthcare of Atlanta is the lead sponsor of 97 studies on the registry; 6 are open to participants now.
Compared within Down Syndrome, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Congenital, Hereditary, and Neonatal Diseases and Abnormalities. The counts are of registry records indexed under each term, refreshed daily. How we classify →
patients' charts from Children's Healthcare of Atlanta
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Exclusion Criteria:
A. Birth weight B. Weight at operation C. Incomplete medical records e.g. patient followed preoperatively elsewhere
The record gives a start of Jan 2001, a primary completion of Mar 2006 and a completion of Feb 2008. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Feb 2008. You cannot join it, but the record below documents what was studied.
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Children's Healthcare of Atlanta