Multi-Center Clinical Database of Infants for the Investigation of Early Nutrition Biomarkers
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Infant Development. Basic parameters: 0 Days — 5 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Primary outcome measures
- Cohort 1: Growth, Development, Diagnoses, and Long-term Outcomes [Time frame: 5 years]
- Cohort 2: Growth, Development, Diagnoses, and Long-term Outcomes [Time frame: 5 years]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-control
Study locations
United States · 9 centers
- Alabama Clinical Therapeutics, LLC (Cohort 1) — Birmingham
- Watching Over Mothers & Babies (Cohort 1) — Tuscan
- The Children's Clinic of Jonesboro (Cohort 1) — Jonesboro
- Clinical Research Prime (Cohort 1) — Idaho Falls
- Pediatric Associates Mt. Carmel (Cohort 1) — Cincinnati
- Coastal Pediatric Research (Cohort 1) — Charleston
- Coastal Pediatric Research (Cohort 1) — Summerville
- Holston Medical Group (Cohort 1) — Kingsport
- … and 1 more center
Identifiers
NCT: NCT05049655 · BH-10118-02