Multi-Center Clinical Database of Infants for the Investigation of Early Nutrition Biomarkers
- Conditions
- Infant Development
- Registration Number
- NCT05049655
- Lead Sponsor
- ByHeart
- 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.
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 2000
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Cohort 2: Growth, Development, Diagnoses, and Long-term Outcomes 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 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (8)
Clinical Research Prime (Cohort 1)
🇺🇸Idaho Falls, Idaho, United States
Tanner Clinic (Cohort 1)
🇺🇸Layton, Utah, United States
Alabama Clinical Therapeutics, LLC (Cohort 1)
🇺🇸Birmingham, Alabama, United States
Watching Over Mothers & Babies (Cohort 1)
🇺🇸Tucson, Arizona, United States
The Children's Clinic of Jonesboro (Cohort 1)
🇺🇸Jonesboro, Arkansas, United States
Pediatric Associates Mt. Carmel (Cohort 1)
🇺🇸Cincinnati, Ohio, United States
Coastal Pediatric Research (Cohort 1)
🇺🇸Summerville, South Carolina, United States
Holston Medical Group (Cohort 1)
🇺🇸Kingsport, Tennessee, United States