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

Launched by BYHEART · Sep 9, 2021

Keywords

ClinConnect Summary

This is an observational study called the Multi-Center Clinical Database of Infants for the Investigation of Early Nutrition Biomarkers. It will collect medical history from about 2,000 infants to build a long-term picture of how early feeding may relate to growth, development, health diagnoses, and other outcomes up to age 5. There are two groups: Cohort 1 includes babies who completed a previous study (SS-101-18) and will compare those fed ByHeart study formula, other commercial formula, or breast milk; Cohort 2 includes babies up to about 4 months old at enrollment and looks at growth and health differences across any early feeding method. The goal is to learn if early nutrition is linked to later health and to help inform future ByHeart products.

Who can join? The study will enroll around 2,000 infants of either sex, from birth up to age 5, at multiple U.S. sites. Key eligibility includes parental consent and willingness to participate. For Cohort 1, babies must have participated in SS-101-18 through a certain visit date; for Cohort 2, babies must be younger than 120 days at enrollment. Exclusions include not having participated in SS-101-18 (for Cohort 1) or having a medical condition likely to affect growth. This study is currently enrolling by invitation, started in 2021, with an estimated completion around 2026. Results aren’t available yet, and data sharing with other researchers is undecided. The sponsor is ByHeart.

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.