Clinical Trials in the USA / NCT05049655
Enrolling by invitation
Observational
Multi-Center Clinical Database of Infants for the Investigation of Early Nutrition Biomarkers
NCT05049655 · tracked via the Priya Life Science USA tracker
Condition(s) studied
Infant Development
Study summary
An observational study to generate a long-term outcome database from medical records for infants who completed protocol SS-101-18 or infants who are breastfed, fed commercial formula, or fed a marketed ByHeart formula.
Eligibility
Inclusion Criteria Cohort 1:
* Active participation in SS-101-18 through Visit 9
* Provision of signed and dated informed consent form (ICF) by parent or legally authorized representative (LAR)
* Stated willingness to comply with all study procedures by parent or LAR.
Exclusion Criteria Cohort 1:
* Did not participate in SS-101-18
* Participated in SS-101-18 that withdrew from the study for any reason prior to Visit 9
* Anything that in the opinion of the Investigator is likely to interfere with participation in the registry.
Inclusion Criteria Cohort 2:
* Be less than 120 days old at the time of enrollment
* Provision of signed and dated informed consent form (ICF) by parent or legally authorized representative (LAR)
* Stated willingness to comply with all study procedures by parent or LAR.
Exclusion Criteria Cohort 2:
* Participation in SS-101-18
* Anything that, in the opinion of the Investigator, is likely to interfere with participation in the registry.
* In the opinion of the investigator, has a diagnosed medical condition or genetic abnormality known to impact growth or development.
Primary outcome measure(s)
- Cohort 1: Growth, Development, Diagnoses, and Long-term Outcomes — 5 years
The registry will be utilized to investigate growth, development, diagnoses, and long-term outcomes of infants who received ByHeart study formula, commercially available formula, or breastmilk in the SS-101-18 protocol. - Cohort 2: Growth, Development, Diagnoses, and Long-term Outcomes — 5 years
A clinical database of children of all feeding options; to describe any difference in growth, development, medical diagnoses, and outcomes based on early nutritional intake
Trial sites (9)
| Facility | City | Region | Status |
|---|---|---|---|
| Alabama Clinical Therapeutics, LLC (Cohort 1) | Birmingham | Alabama | |
| Watching Over Mothers & Babies (Cohort 1) | Tuscan | Arizona | |
| The Children's Clinic of Jonesboro (Cohort 1) | Jonesboro | Arkansas | |
| Clinical Research Prime (Cohort 1) | Idaho Falls | Idaho | |
| Pediatric Associates Mt. Carmel (Cohort 1) | Cincinnati | Ohio | |
| Coastal Pediatric Research (Cohort 1) | Charleston | South Carolina | |
| Coastal Pediatric Research (Cohort 1) | Summerville | South Carolina | |
| Holston Medical Group (Cohort 1) | Kingsport | Tennessee | |
| Tanner Clinic (Cohort 1) | Layton | Utah |
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05049655 on ClinicalTrials.gov ↗ ← All trials in the USA