Multi-Center Clinical Database of Infants for the Investigation of Early Nutrition Biomarkers
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Infant Development
- Sponsor
- ByHeart
- Enrollment
- 2000
- Locations
- 8
- Primary Endpoint
- Cohort 2: Growth, Development, Diagnoses, and Long-term Outcomes
- Status
- Enrolling by Invitation
- Last Updated
- 11 months ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Cohort 2: Growth, Development, Diagnoses, and Long-term Outcomes
Time Frame: 5 years
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
Cohort 1: Growth, Development, Diagnoses, and Long-term Outcomes
Time Frame: 5 years
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.