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

Launched by BYHEART · Sep 9, 2021

Keywords

ClinConnect Summary

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 commerc...

Gender

ALL

Eligibility criteria

• 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.