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

Infant Development Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05049655
• Other study ID #: BH-10118-02
• Status: Enrolling by invitation
• Start date: October 19, 2021
• Est. completion date: October 2026

Study information

• Verified date: November 2023
• Source: ByHeart
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 2000
• Est. completion date: October 2026
• Est. primary completion date: October 2026
• Gender: All
• Age group: 0 Days to 5 Years

Eligibility

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.

Related Conditions & MeSH terms

• Infant Development

Locations

Country	Name	City	State
United States	Alabama Clinical Therapeutics, LLC (Cohort 1)	Birmingham	Alabama
United States	Coastal Pediatric Research (Cohort 1)	Charleston	South Carolina
United States	Pediatric Associates Mt. Carmel (Cohort 1)	Cincinnati	Ohio
United States	The Children's Clinic of Jonesboro (Cohort 1)	Jonesboro	Arkansas
United States	Holston Medical Group (Cohort 1)	Kingsport	Tennessee
United States	Coastal Pediatric Research (Cohort 1)	Summerville	South Carolina
United States	PAS Research (Cohort 1)	Tampa	Florida
United States	Watching Over Mothers & Babies (Cohort 1)	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
ByHeart

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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