Infant DevelopmentNCT05049655
Multi-Center Clinical Database of Infants for the Investigation of Early Nutrition Biomarkers
An observational study of Infant Development, run by ByHeart at 9 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 0 days to 5 years
- Conditions the study is for
- Infant Development
- How many people
- 2,000 participants
- Where
- 9 sitesUnited States
- Study dates
- 19 Oct 2021to Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 days to 5 years
- All sexes
- No healthy volunteers
- Child
Study population: Approximately 2000 infants will be enrolled in this study.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
United States9 sites
Alabama Clinical Therapeutics, LLC (Cohort 1)
Birmingham, Alabama, 35205
Coastal Pediatric Research (Cohort 1)
Charleston, South Carolina, 29414
Pediatric Associates Mt. Carmel (Cohort 1)
Cincinnati, Ohio, 45245
Clinical Research Prime (Cohort 1)
Idaho Falls, Idaho, 83404
The Children's Clinic of Jonesboro (Cohort 1)
Jonesboro, Arkansas, 72401
Holston Medical Group (Cohort 1)
Kingsport, Tennessee, 37660
Tanner Clinic (Cohort 1)
Layton, Utah, 84041
Coastal Pediatric Research (Cohort 1)
Summerville, South Carolina, 29486
Watching Over Mothers & Babies (Cohort 1)
Tuscan, Arizona, 87512
About this study
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.
Read the 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.
- Conditions
- Infant Development
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 years
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
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2021
- Study start19 Oct 2021
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infant DevelopmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ByHeart
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Devon Kuehn, M.D., Study director, ByHeart
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05049655
- Sponsor's protocol ID
- BH-10118-02
- Status last verified
- May 2025
- First submitted
- 9 Sep 2021
- Last updated
- 25 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-Center Clinical Database of Infants for the Investigation of Early Nutrition Biomarkers
- ClinicalTrials.gov ID
- NCT05049655
- Acronym / sponsor ID
- BH-10118-02
- Conditions
- Infant Development
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- ByHeartIndustry (pharma, biotech, devices)
- Study start
- 19 Oct 2021 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 20 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 0 days to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Approximately 2000 infants will be enrolled in this study.
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cohort 1: Growth, Development, Diagnoses, and Long-term Outcomes
Time frame: 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.
Cohort 2: Growth, Development, Diagnoses, and Long-term Outcomes
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Devon Kuehn, M.D. study director
ByHeart
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infant Development, run by ByHeart at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 25 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cohort 1: Growth, Development, Diagnoses, and Long-term Outcomes (time frame: 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2025.