ByHeart
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.
The first Cohort (Cohort 1) goals of the registry include: to compile a clinical database of children who were fed in SS-101-18 by breastfeeding, commercial formula, or ByHeart formula; to investigate any difference in demographics, growth, development, medical diagnoses, and outcomes between the feeding groups, and in particular to compare ByHeart formula-fed infants against commercial formula-fed infants, and referenced against breastfed infants. The second Cohort (Cohort 2) goals of the registry include: to compile a clinical database of children who were fed by breastfeeding or commercial…
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…