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NCT05049655

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

Enrolling by Invitation
Not specifiedAges 0–5Observational
ByHeart
~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

Infant Development

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Infant Development

NCT05049655

Where you'd take part

This study runs at 9 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Alabama Clinical Therapeutics, LLC (Cohort 1)

    Birmingham, Alabamano site contact published

  • Clinical Research Prime (Cohort 1)

    Idaho Falls, Idahono site contact published

  • Coastal Pediatric Research (Cohort 1)

    Charleston, South Carolinano site contact published

  • Coastal Pediatric Research (Cohort 1)

    Summerville, South Carolinano site contact published

  • Holston Medical Group (Cohort 1)

    Kingsport, Tennesseeno site contact published

  • Pediatric Associates Mt. Carmel (Cohort 1)

    Cincinnati, Ohiono site contact published

  • Tanner Clinic (Cohort 1)

    Layton, Utahno site contact published

  • The Children's Clinic of Jonesboro (Cohort 1)

    Jonesboro, Arkansasno site contact published

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Devon Kuehn, M.D. · STUDY_DIRECTOR · ByHeart

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

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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