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

NCT05049655 | Enrolling By Invitation

• 1 other identifier: BH-10118-02
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 9

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.

Conditions

Infant Development

Outcome Measures

Primary Outcomes (2)

• Cohort 1: Growth, Development, Diagnoses, and Long-term Outcomes

  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.

  5 years

• Cohort 2: Growth, Development, Diagnoses, and Long-term Outcomes

  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

  5 years

Study Arms (2)

Cohort 1

Babies who were fed commercial formula, study formula, or were fed with human milk in the SS-101-18 study that consented to the BH-10118-02 study

Cohort 2

Babies fed with commercial formula (including ByHeart formula) or fed with human milk

Eligibility Criteria

• Age: 0 Days - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Approximately 2000 infants will be enrolled in this study.

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.
• 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.

Sponsors & Collaborators

• ByHeart: lead

Study Sites (9)

Alabama Clinical Therapeutics, LLC (Cohort 1)

Birmingham, Alabama, 35205, United States

Location

Watching Over Mothers & Babies (Cohort 1)

Tuscan, Arizona, 87512, United States

Location

The Children's Clinic of Jonesboro (Cohort 1)

Jonesboro, Arkansas, 72401, United States

Location

Clinical Research Prime (Cohort 1)

Idaho Falls, Idaho, 83404, United States

Location

Pediatric Associates Mt. Carmel (Cohort 1)

Cincinnati, Ohio, 45245, United States

Location

Coastal Pediatric Research (Cohort 1)

Charleston, South Carolina, 29414, United States

Location

Coastal Pediatric Research (Cohort 1)

Summerville, South Carolina, 29486, United States

Location

Holston Medical Group (Cohort 1)

Kingsport, Tennessee, 37660, United States

Location

Tanner Clinic (Cohort 1)

Layton, Utah, 84041, United States

Location

Study Officials

• Devon Kuehn, M.D.

  ByHeart

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2021
• First Posted: September 20, 2021
• Study Start: October 19, 2021
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: May 25, 2025

Record last verified: 2025-05

Locations

US (9)