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

Sponsor
ByHeart (Industry)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05049655
Collaborator
(none)
2,000
Enrollment
8
Locations
59.4
Anticipated Duration (Months)
250
Patients Per Site
4.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    2000 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Other
    Official Title:
    Multi-Center Clinical Database of Infants for the Investigation of Early Nutrition Biomarkers
    Actual Study Start Date :
    Oct 19, 2021
    Anticipated Primary Completion Date :
    Oct 1, 2026
    Anticipated Study Completion Date :
    Oct 1, 2026

    Arms and Interventions

    Arm Intervention/Treatment
    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

    Outcome Measures

    Primary Outcome Measures

    1. Cohort 1: Growth, Development, Diagnoses, and Long-term Outcomes [5 years]

      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.

    2. Cohort 2: Growth, Development, Diagnoses, and Long-term Outcomes [5 years]

      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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    0 Days to 5 Years
    Sexes Eligible for Study:
    All
    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.

    Contacts and Locations

    Locations

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

    Sponsors and Collaborators

    • ByHeart

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    ByHeart
    ClinicalTrials.gov Identifier:
    NCT05049655
    Other Study ID Numbers:
    • BH-10118-02
    First Posted:
    Sep 20, 2021
    Last Update Posted:
    Aug 17, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Aug 17, 2022