NCT05049655
Multi-Center Clinical Database of Infants for the Investigation of Early Nutrition Biomarkers
Enrolling by Invitation
Not specifiedAges 0–5ObservationalByHeart
~2,000 participants
Updated 2025-05-25 on ClinicalTrials.gov
At a glance
Recruiting sites
0 of 9 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Cohort 1: Growth, Development, Diagnoses, and Long-term Outcomes
Measured over 5 years
+1 more outcome measured
Conditions
Where it's being run
9 sites across 8 statesSouth Carolina2
Alabama1
Arizona1
Arkansas1
Idaho1
Ohio1
Tennessee1
Utah1
Study leadership
- Devon Kuehn, M.D. · STUDY_DIRECTOR · ByHeart
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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.
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
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.
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.
What this trial measures
- Cohort 1: Growth, Development, Diagnoses, and Long-term Outcomes5 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.
- Cohort 2: Growth, Development, Diagnoses, and Long-term Outcomes5 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