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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-10-19

Study Completion Date

2026-10-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Infant Development

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

OTHER

Study Groups

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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

No interventions assigned to this group

Cohort 2

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

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* 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 Criteria

* 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.

Minimum Eligible Age

0 Days

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No