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

Infant Development Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05049655
Study type Observational
Source ByHeart
Contact
Status Enrolling by invitation
Phase
Start date October 19, 2021
Completion date October 2026
View Details
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