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| Name | Class |
|---|---|
| Paidion Research, Inc. | INDUSTRY |
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The purpose of this study is to demonstrate that a new infant formula for term infants supports age-appropriate growth. This study is designed in accordance with Good Clinical Practice guidelines and the requirements of the Code of Federal Regulations, 21CFR106.96. In this randomized, controlled trial (RCT), healthy, term, formula-fed (FF) infants will be randomized to one of two infant formulas: a standard, commercially-available infant formula for term infants (CF) or the study formula for term infants (SF) for 16 weeks. A reference group of human milk-fed infants will also be enrolled. The primary efficacy objective is to compare the growth of infants randomized to the study infant formula (SF) versus growth of infants randomized to the standard commercial infant formula (CF).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Formula (SF) | Experimental | New infant formula for term infants |
|
| Comparator Formula (CF) | Active Comparator | Commercially available infant formula for term infants |
|
| Human Milk Reference Group | No Intervention | Human milk |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Study Formula (SF) | Other | New infant formula for term infants fed ad lib |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Weight Gain Velocity | G/D | 0 - 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Weight Measures | KG | 0 - 16 weeks |
| Length Measures | CM | 0 - 16 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Devon Kuehn, MD | ByHeart, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alabama Clinical Therapeutics | Birmingham | Alabama | 35126 | United States | ||
| Watching Over Mothers and Babies |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42095870 | Derived | 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. | |
| 35666855 | Derived | Kuehn 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. |
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| Comparator Formula (CF) |
| Other |
Commercially available infant formula for term infants fed ad lib |
|
| Length Gain Velocity |
CM/D |
| 0 - 16 weeks |
| Head Circumference Measures | CM | 0 - 16 weeks |
| Weight for age Z-scores | Weight for age Z-scores compared to World Health Organization (WHO) growth standards | 0 - 16 weeks |
| Length for age Z-scores | Length for age Z-scores compared to WHO growth standards | 0 - 16 weeks |
| Head circumference for age Z-scores | Head circumference for age Z-scores compared to WHO growth standards | 0 - 16 weeks |
| Weight for length Z-scores | Weight for length Z-scores compared to WHO growth standards | 0 - 16 weeks |
| 72-hr record of formula intake at each study visit | OZ/D | 0 - 16 weeks |
| Blood concentrations of Interleukin-6 (pg/mL), Interleukin-10 (pg/mL), and tumor necrosis factor-alpha (pg/mL) | Concentration | 16 weeks |
| Blood concentrations of amino acids (umol/L) | Concentration | 16 weeks |
| Human milk composition (concentrations of proteins, lipids, carbohydrates, vitamins, and minerals | Concentration | 3 weeks, 7 weeks |
| Medically-diagnosed adverse events collected throughout the study period | Frequency | 0 through 16 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]). | 0 - 16 weeks |
| Parent report of infant stool frequency at each study visit | Mean | 0 - 16 weeks |
| Parent report of infant disposition (fussiness, crying, gas, spit up, Infant Characteristics Questionnaire) at each study visit | Mean | 0 - 16 weeks |
| Stool microbiome | Fecal microbial taxa and community abundance | 2 weeks, 16 weeks |
| Stool metabolome | Targeted and Untargeted Metabolomics | 2 weeks, 16 weeks |
| Tucson |
| Arizona |
| 85712 |
| United States |
| The Children's Clinic of Jonesboro, P.A. | Jonesboro | Arkansas | 72401 | United States |
| Applied Research Center of Arkansas | Little Rock | Arkansas | 72212 | United States |
| San Gabriel Women's Health | Arcadia | California | 91007 | United States |
| Northern California Research | Sacramento | California | 95812 | United States |
| Optum | Colorado Springs | Colorado | 80922 | United States |
| Topaz Clinical Research | Apopka | Florida | 32703 | United States |
| Sarkis Clinical Trials | Gainesville | Florida | 32607 | United States |
| Avanza Medical Research | Pensacola | Florida | 32503 | United States |
| PAS-Research | Tampa | Florida | 33613 | United States |
| Clinical Research Prime | Idaho Falls | Idaho | 83404 | United States |
| Southern Clinical Research | Zachary | Louisiana | 70791 | United States |
| Sierra Clinical Research | Las Vegas | Nevada | 89106 | United States |
| Pediatric Associates of Mt. Carmel, Inc | Cincinnati | Ohio | 45245 | United States |
| Schear Family Practice | Dayton | Ohio | 45406 | United States |
| Pediatric Associates of Fairfield, Inc. | Fairfield | Ohio | 45014 | United States |
| Institute of Clinical Research | Mentor | Ohio | 44060 | United States |
| Coastal Pediatric Research | Charleston | South Carolina | 29414 | United States |
| Coastal Pediatric Associates | Summerville | South Carolina | 29486 | United States |
| HMG Primary Care at Sapling Grove | Bristol | Tennessee | 37620 | United States |
| Jackson Clinic North | Jackson | Tennessee | 38305 | United States |
| HMG Pediatrics at Kingsport | Kingsport | Tennessee | 37660 | United States |
| Houston Clinical Research Associates | Houston | Texas | 77090 | United States |
| DCOL Center for Clinical Research | Longview | Texas | 75165 | United States |
| ACRC Trials Plano Pediatrics | Plano | Texas | 75093 | United States |
| Tanner Clinic | Layton | Utah | 84041 | United States |