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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Infant Development

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.

• Study Type: Observational
• Enrollment (Estimated): 2000

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35205
      • Alabama Clinical Therapeutics, LLC (Cohort 1)
  • Arizona
    • Tucson, Arizona, United States, 87512
      • Watching Over Mothers & Babies (Cohort 1)
  • Arkansas
    • Jonesboro, Arkansas, United States, 72401
      • The Children's Clinic of Jonesboro (Cohort 1)
  • Florida
    • Tampa, Florida, United States, 33613
      • PAS Research (Cohort 1)
  • Ohio
    • Cincinnati, Ohio, United States, 45245
      • Pediatric Associates Mt. Carmel (Cohort 1)
  • South Carolina
    • Charleston, South Carolina, United States, 29414
      • Coastal Pediatric Research (Cohort 1)
    • Summerville, South Carolina, United States, 29486
      • Coastal Pediatric Research (Cohort 1)
  • Tennessee
    • Kingsport, Tennessee, United States, 37660
      • Holston Medical Group (Cohort 1)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 second to 5 years (Child)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Approximately 2000 infants will be enrolled in this study.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Other

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: ByHeart
• Investigators: Study Director: Devon Kuehn, M.D., ByHeart

Study record dates

Study Major Dates

• Study Start (Actual): October 19, 2021
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: September 9, 2021
• First Submitted That Met QC Criteria: September 9, 2021
• First Posted (Actual): September 20, 2021

Study Record Updates

• Last Update Posted (Actual): November 30, 2023
• Last Update Submitted That Met QC Criteria: November 28, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: BH-10118-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No