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

ByHeart

Status: Invitation-only

Conditions: Infant Development

Study type: Observational

Funder types: Industry

Identifiers

NCT05049655

BH-10118-02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,000 estimated patients

Sex: All

Ages: Under 5 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

2,000 participants in 2 patient groups

Cohort 1

Description:

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

Description:

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