NCT05049655

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

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 2,000 (estimated)
• Sponsor: ByHeart · Industry
• Sex: All
• Age: 0 Days – 5 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Infant Development

Timeline

• Start date: 2021-10-19
• Primary completion: 2026-10-01
• Completion: 2026-10-01
• First posted: 2021-09-20
• Last updated: 2025-05-25

Locations

9 sites across 1 country: United States