Multi-Center Clinical Database of Infants for the Investigation of Early Nutrition Biomarkers

Study Overview
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Brief Summary
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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
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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.

Official Title
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Multi-Center Clinical Database of Infants for the Investigation of Early Nutrition Biomarkers

Conditions
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Infant Development

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 0 Days
Maximum Age: 5 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort 1<br>Babies who were fed commercial formula, study formula, or were fed with human milk in the SS-101-18 study that consented to the BH-10118-02 study | |
| Cohort 2<br>Babies fed with commercial formula (including ByHeart formula) or fed with human milk | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cohort 1: Growth, Development, Diagnoses, and Long-term Outcomes | 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. | 5 years | 
| Cohort 2: Growth, Development, Diagnoses, and Long-term Outcomes | 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 | 5 years |