🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in the USA / NCT05049655
Enrolling by invitation Observational

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

NCT05049655 · tracked via the Priya Life Science USA tracker
Sponsor
ByHeart
Phase
Observational
Started
2021-10-19
Last updated
2025-05-25

Condition(s) studied

Infant Development

Study 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.

Eligibility

Sex
ALL
Min age
0 Days
Max age
5 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (9)

FacilityCityRegionStatus
Alabama Clinical Therapeutics, LLC (Cohort 1) Birmingham Alabama
Watching Over Mothers & Babies (Cohort 1) Tuscan Arizona
The Children's Clinic of Jonesboro (Cohort 1) Jonesboro Arkansas
Clinical Research Prime (Cohort 1) Idaho Falls Idaho
Pediatric Associates Mt. Carmel (Cohort 1) Cincinnati Ohio
Coastal Pediatric Research (Cohort 1) Charleston South Carolina
Coastal Pediatric Research (Cohort 1) Summerville South Carolina
Holston Medical Group (Cohort 1) Kingsport Tennessee
Tanner Clinic (Cohort 1) Layton Utah
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05049655 on ClinicalTrials.gov ↗ ← All trials in the USA