Infant Development
Conditions
Brief 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.
Detailed description
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 formula (including ByHeart formula); to describe any difference in growth, development, medical diagnoses, and outcomes based on early nutritional intake; and to inform or facilitate development of future ByHeart products.
Interventions
None listed
Sponsors
ByHeart
Study design
Observational model
CASE_CONTROL
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
0 Days to 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed