Clinical trial NCT05049655: Multi-Center Clinical Database of Infants for the Investigation of Early Nutrition Biomarkers
Official title: Multi-Center Clinical Database of Infants for the Investigation of Early Nutrition Biomarkers
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Infant Development
Lead sponsor: ByHeart
Sponsor class: INDUSTRY
First posted: 2021-09-20
Enrollment: 2000
Sex: ALL
Minimum age (years): 0
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Approximately 2000 infants will be enrolled in this study.

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.

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.

Eligibility 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.

Primary outcomes:
measure: Cohort 1: Growth, Development, Diagnoses, and Long-term Outcomes
timeFrame: 5 years
measure: Cohort 2: Growth, Development, Diagnoses, and Long-term Outcomes
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Alabama Clinical Therapeutics, LLC (Cohort 1)
state: Alabama
city: Tuscan
country: United States
facility: Watching Over Mothers & Babies (Cohort 1)
state: Arizona
city: Jonesboro
country: United States
facility: The Children's Clinic of Jonesboro (Cohort 1)
state: Arkansas
city: Idaho Falls
country: United States
facility: Clinical Research Prime (Cohort 1)
state: Idaho
city: Cincinnati
country: United States
facility: Pediatric Associates Mt. Carmel (Cohort 1)
state: Ohio
city: Charleston
country: United States
facility: Coastal Pediatric Research (Cohort 1)
state: South Carolina
city: Summerville
country: United States
facility: Coastal Pediatric Research (Cohort 1)
state: South Carolina
city: Kingsport
country: United States
facility: Holston Medical Group (Cohort 1)
state: Tennessee
city: Layton
country: United States
facility: Tanner Clinic (Cohort 1)
state: Utah
Study officials:
affiliation: ByHeart
name: Devon Kuehn, M.D.
role: STUDY_DIRECTOR
References: