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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
ByHeart
Study ID
NCT05049655
Status
Enrolling By Invitation

Conditions

  • Infant Development

Eligibility Criteria

Sex
ALL
Age
0 Days - 5 Years
Healthy Volunteers
Not accepted

Study Details

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.

Key Dates

First listed
Sep 20, 2021
Start date
Oct 19, 2021
Status verified
May 2025
Primary completion
Oct 31, 2026
Completion
Oct 31, 2026

Study Design

Enrollment
2,000 participants (estimated)

Arms

  • Arm: 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
  • Arm: Cohort 2
    Babies fed with commercial formula (including ByHeart formula) or fed with human milk

Primary Outcome Measure

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

Locations (9)

FacilityCityStateZIPSite coordinators
Alabama Clinical Therapeutics, LLC (Cohort 1)BirminghamAlabama35205-
Watching Over Mothers & Babies (Cohort 1)TuscanArizona87512-
The Children's Clinic of Jonesboro (Cohort 1)JonesboroArkansas72401-
Clinical Research Prime (Cohort 1)Idaho FallsIdaho83404-
Pediatric Associates Mt. Carmel (Cohort 1)CincinnatiOhio45245-
Coastal Pediatric Research (Cohort 1)CharlestonSouth Carolina29414-
Coastal Pediatric Research (Cohort 1)SummervilleSouth Carolina29486-
Holston Medical Group (Cohort 1)KingsportTennessee37660-
Tanner Clinic (Cohort 1)LaytonUtah84041-

Find similar trials in Birmingham, AL

By research site
Alabama Clinical Therapeutics, LLC (Cohort 1)· Birmingham, ALWatching Over Mothers & Babies (Cohort 1)· Tuscan, AZThe Children's Clinic of Jonesboro (Cohort 1)· Jonesboro, ARClinical Research Prime (Cohort 1)· Idaho Falls, IDPediatric Associates Mt. Carmel (Cohort 1)· Cincinnati, OHCoastal Pediatric Research (Cohort 1)· Charleston, SC

Related Studies