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
Sex
ALL
Min age
0 Days
Max age
5 Years
Healthy volunteers
No
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.
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