HealthyNCT04389606
Follow-up Study of Growth, Safety, and Efficacy of an Infant Formula for Healthy Term Infants
A study testing Study Formula (SF) and Comparator Formula (CF) in people with Healthy and Term Infants, run by ByHeart at 27 sites in United States.
Trial summary
The purpose of this two-month follow-up study is to continue to follow growth, safety, and other health outcomes of infants fed a new infant formula for term infants or comparator formula. A reference group of human milk-fed infants will also be followed. Read more about this study
- Who is it for?
- Ages 16 to 19 weeksHealthy volunteers can take part
- Conditions the study is for
- Healthy, Term Infants
- What is being tested?
- Study Formula (SF) and Comparator Formula (CF)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 311 participants
- Where
- 27 sitesUnited States
- Study dates
- 12 May 2020to 11 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 16 to 19 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Subjects who enrolled and completed the previous phase of the clinical trial: NCT04218929 "Evaluation of Growth, Safety, and Efficacy of an Infant Formula for Healthy Term Infants"
Who cannot join
- Subjects who did not enroll in the previous phase of the clinical trial: NCT04218929 "Evaluation of Growth, Safety, and Efficacy of an Infant Formula for Healthy Term Infants"
Trial locations and contacts
27 sites in 1 country.
27 sites in 1 country
United States27 sites
Topaz Clinical Research
Apopka, Florida, 32703
San Gabriel Women's Health
Arcadia, California, 91007
Alabama Clinical Therapeutics
Birmingham, Alabama, 35126
HMG Primary Care at Sapling Grove
Bristol, Tennessee, 37620
Coastal Pediatric Research
Charleston, South Carolina, 29414
Pediatric Associates of Mt. Carmel, Inc
Cincinnati, Ohio, 45245
Optum
Colorado Springs, Colorado, 80922
Schear Family Practice
Dayton, Ohio, 45406
Pediatric Associates of Fairfield, Inc.
Fairfield, Ohio, 45014
Sarkis Clinical Trials
Gainesville, Florida, 32607
Houston Clinical Research Associates
Houston, Texas, 77090
Clinical Research Prime
Idaho Falls, Idaho, 83404
Jackson Clinic North
Jackson, Tennessee, 38305
The Children's Clinic of Jonesboro, P.A.
Jonesboro, Arkansas, 72401
HMG Pediatrics at Kingsport
Kingsport, Tennessee, 37660
Sierra Clinical Research
Las Vegas, Nevada, 89106
Tanner Clinic
Layton, Utah, 84041
Applied Research Center of Arkansas
Little Rock, Arkansas, 72212
DCOL Center for Clinical Research
Longview, Texas, 75165
Institute of Clinical Research
Mentor, Ohio, 44060
Avanza Medical Research
Pensacola, Florida, 32503
ACRC Trials Plano Pediatrics
Plano, Texas, 75093
Northern California Research
Sacramento, California, 95812
Coastal Pediatric Associates
Summerville, South Carolina, 29486
PAS-Research
Tampa, Florida, 33613
Watching Over Mothers and Babies
Tucson, Arizona, 85712
Southern Clinical Research
Zachary, Louisiana, 70791
About this study
The purpose of this two-month follow-up study is to continue to follow growth, safety, and other health outcomes of infants fed a new infant formula for term infants or comparator formula. A reference group of human milk-fed infants will also be followed. This study is designed in accordance with Good Clinical Practice guidelines.
- Conditions
- Healthy, Term Infants
- Being tested
- Study Formula (SF), Comparator Formula (CF)
- Keywords
- Infant, Infant Formula, Healthy Subjects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Study Formula (SF)Other
New infant formula for term infants fed ad lib
Comparator Formula (CF)Other
Commercially available infant formula for term infants fed ad lib
| Study group | Role | What they receive |
|---|---|---|
| Study Formula (SF) | Experimental | New infant formula for term infants Receives: Other: Study Formula (SF); Other: Comparator Formula (CF) |
| Comparator Formula (CF) | Active comparator | Commercially available infant formula for term infants Receives: Other: Study Formula (SF); Other: Comparator Formula (CF) |
| Human Milk Reference Group | No intervention | Human milk |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight Gain Velocity
G/D
Measured: up to 24 weeks
Secondary outcomes (18)
Weight Measures
KG
Measured: 20 weeks, 24 weeks
Length Measures
CM
Measured: 20 weeks, 24 weeks
Length Gain Velocity
CM/D
Measured: 20 weeks, 24 weeks
Head Circumference Measures
CM
Measured: 20 weeks, 24 weeks
Weight for age Z-scores
Weight for age Z-scores compared to World Health Organization (WHO) growth standards
Measured: 20 weeks, 24 weeks
Length for age Z-scores
Length for age Z-scores compared to WHO growth standards
Measured: 20 weeks, 24 weeks
Head circumference for age Z-scores
Head circumference for age Z-scores compared to WHO growth standards
Measured: 20 weeks, 24 weeks
Weight for length Z-scores
Weight for length Z-scores compared to WHO growth standards
Measured: 20 weeks, 24 weeks
72-hr record of formula intake at each study visit
oz/d
Measured: 20 weeks, 24 weeks
Blood concentrations of Interleukin-6 (pg/mL), Interleukin-10 (pg/mL), and tumor necrosis factor-alpha (pg/mL)
Concentration
Measured: 24 weeks
Blood concentrations of amino acids (umol/L)
Concentration
Measured: 24 weeks
Human milk composition (concentrations of proteins, lipids, carbohydrates, vitamins, and minerals
Concentration
Measured: 24 weeks
Medically-diagnosed adverse events collected throughout the study period
Frequency
Measured: 16-24 weeks
Parent rating of infant stool consistency at each study visit
Mean. Quinlan et al Likert scale; 0=no bowel movement, 1=hard [dry hard pellets], 2=formed [definite shape, not dry], 3=soft [no definite shape, pasty], 4=loose [no shape, some water], 5=watery [no shape, mainly water]).
Measured: 20 weeks, 24 weeks
Parent report of infant stool frequency at each study visit
Mean
Measured: 20 weeks, 24 weeks
Parent report of infant disposition (fussiness, crying, gas, spit up, Infant Characteristics Questionnaire) at each study visit
Mean
Measured: 20 weeks, 24 weeks
Stool microbiome
Fecal microbial taxa and community abundance
Measured: 24 weeks
Stool metabolome
Targeted and Untargeted Metabolomics
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2020
- Study start12 May 2020
- Primary completion11 Jun 2021
- Study completion11 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 311 participants (actual)
Sponsor and investigators
- Lead sponsor
- ByHeart
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Paidion Research, Inc.
- Responsible party
- Sponsor
- Investigators
- Devon Kuehn, MD, Study director, ByHeart, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04389606
- Sponsor's protocol ID
- SS-101-Follow-up
- Status last verified
- Jul 2021
- First submitted
- 12 May 2020
- Last updated
- 21 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Orenstein D, Kuehn D, Knezevic A, Carney M, Camara S, Peltier C. Infant Formula With Added Alpha-Lactalbumin Improves Nighttime Feeding Patterns With Implications for Sleep Quality. J Am Nutr Assoc. 2026 May 7:1-7. doi: 10.1080/27697061.2026.2659830. Online ahead of print.
PubMed 42095870Kuehn D, Zeisel SH, Orenstein DF, German JB, Field CJ, Teerdhala S, Knezevic A, Patil S, Donovan SM, Lonnerdal B. Effects of a Novel High-Quality Protein Infant Formula on Energetic Efficiency and Tolerance: A Randomized Trial. J Pediatr Gastroenterol Nutr. 2022 Oct 1;75(4):521-528. doi: 10.1097/MPG.0000000000003490. Epub 2022 Jun 6.
PubMed 35666855
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Follow-up Study of Growth, Safety, and Efficacy of an Infant Formula for Healthy Term Infants
- ClinicalTrials.gov ID
- NCT04389606
- Acronym / sponsor ID
- SS-101-Follow-up
- Conditions
- Healthy, Term Infants
- Keywords
- Infant, Infant Formula, Healthy Subjects
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 311 participants (actual)
- Lead sponsor
- ByHeartIndustry (pharma, biotech, devices)
- Collaborators
- Paidion Research, Inc.
- Study start
- 12 May 2020 (actual)
- Primary completion
- 11 Jun 2021 (actual)
- Study completion
- 11 Jun 2021 (actual)
- First posted
- 15 May 2020 (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.
The purpose of this two-month follow-up study is to continue to follow growth, safety, and other health outcomes of infants fed a new infant formula for term infants or comparator formula. A reference group of human milk-fed infants will also be followed. This study is designed in accordance with Good Clinical Practice guidelines.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Study Formula (SF) | Experimental | Other: Study Formula (SF), Other: Comparator Formula (CF)New infant formula for term infants |
| Comparator Formula (CF) | Active comparator | Other: Study Formula (SF), Other: Comparator Formula (CF)Commercially available infant formula for term infants |
| Human Milk Reference Group | No intervention | –Human milk |
Who may qualify
- Ages
- 16 to 19 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Subjects who enrolled and completed the previous phase of the clinical trial: NCT04218929 "Evaluation of Growth, Safety, and Efficacy of an Infant Formula for Healthy Term Infants"
Key exclusion criteria (1 listed)
- Subjects who did not enroll in the previous phase of the clinical trial: NCT04218929 "Evaluation of Growth, Safety, and Efficacy of an Infant Formula for Healthy Term Infants"
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Study Formula (SF)New infant formula for term infants fed ad lib | Other | Comparator Formula (CF), Study Formula (SF) |
| Comparator Formula (CF)Commercially available infant formula for term infants fed ad lib | Other | Comparator Formula (CF), Study Formula (SF) |
Primary outcome
Weight Gain Velocity
Time frame: up to 24 weeks
G/D
18 secondary outcomes
Weight Measures
Time frame: 20 weeks, 24 weeks
Length Measures
Time frame: 20 weeks, 24 weeks
Length Gain Velocity
Time frame: 20 weeks, 24 weeks
Head Circumference Measures
Time frame: 20 weeks, 24 weeks
Weight for age Z-scores
Time frame: 20 weeks, 24 weeks
Length for age Z-scores
Time frame: 20 weeks, 24 weeks
Head circumference for age Z-scores
Time frame: 20 weeks, 24 weeks
Weight for length Z-scores
Time frame: 20 weeks, 24 weeks
72-hr record of formula intake at each study visit
Time frame: 20 weeks, 24 weeks
Blood concentrations of Interleukin-6 (pg/mL), Interleukin-10 (pg/mL), and tumor necrosis factor-alpha (pg/mL)
Time frame: 24 weeks
Blood concentrations of amino acids (umol/L)
Time frame: 24 weeks
Human milk composition (concentrations of proteins, lipids, carbohydrates, vitamins, and minerals
Time frame: 24 weeks
Medically-diagnosed adverse events collected throughout the study period
Time frame: 16-24 weeks
Parent rating of infant stool consistency at each study visit
Time frame: 20 weeks, 24 weeks
Parent report of infant stool frequency at each study visit
Time frame: 20 weeks, 24 weeks
Parent report of infant disposition (fussiness, crying, gas, spit up, Infant Characteristics Questionnaire) at each study visit
Time frame: 20 weeks, 24 weeks
Stool microbiome
Time frame: 24 weeks
Stool metabolome
Time frame: 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2021.
- Derived from this study: PubMed 42095870Orenstein D, Kuehn D, Knezevic A, Carney M, Camara S, Peltier C. Infant Formula With Added Alpha-Lactalbumin Improves Nighttime Feeding Patterns With Implications for Sleep Quality. J Am Nutr Assoc. 2026 May 7:1-7. doi: 10.1080/27697061.2026.2659830. Online ahead of print.
- Derived from this study: PubMed 35666855Kuehn D, Zeisel SH, Orenstein DF, German JB, Field CJ, Teerdhala S, Knezevic A, Patil S, Donovan SM, Lonnerdal B. Effects of a Novel High-Quality Protein Infant Formula on Energetic Efficiency and Tolerance: A Randomized Trial. J Pediatr Gastroenterol Nutr. 2022 Oct 1;75(4):521-528. doi: 10.1097/MPG.0000000000003490. Epub 2022 Jun 6.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Devon Kuehn, MD study director
ByHeart, Inc.
27 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Study Formula (SF) and Comparator Formula (CF) in people with Healthy and Term Infants, run by ByHeart at 27 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 21 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Weight Gain Velocity (time frame: up to 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04389606, which also lists 2 linked publications.
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 21 Jul 2021.