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| Name | Class |
|---|---|
| Paidion Research, Inc. | INDUSTRY |
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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.
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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 | up to 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Weight Measures | KG | 20 weeks, 24 weeks |
| Length Measures | CM | 20 weeks, 24 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 | 20 weeks, 24 weeks |
| Head Circumference Measures | CM | 20 weeks, 24 weeks |
| Weight for age Z-scores | Weight for age Z-scores compared to World Health Organization (WHO) growth standards | 20 weeks, 24 weeks |
| Length for age Z-scores | Length for age Z-scores compared to WHO growth standards | 20 weeks, 24 weeks |
| Head circumference for age Z-scores | Head circumference for age Z-scores compared to WHO growth standards | 20 weeks, 24 weeks |
| Weight for length Z-scores | Weight for length Z-scores compared to WHO growth standards | 20 weeks, 24 weeks |
| 72-hr record of formula intake at each study visit | oz/d | 20 weeks, 24 weeks |
| Blood concentrations of Interleukin-6 (pg/mL), Interleukin-10 (pg/mL), and tumor necrosis factor-alpha (pg/mL) | Concentration | 24 weeks |
| Blood concentrations of amino acids (umol/L) | Concentration | 24 weeks |
| Human milk composition (concentrations of proteins, lipids, carbohydrates, vitamins, and minerals | Concentration | 24 weeks |
| Medically-diagnosed adverse events collected throughout the study period | Frequency | 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]). | 20 weeks, 24 weeks |
| Parent report of infant stool frequency at each study visit | Mean | 20 weeks, 24 weeks |
| Parent report of infant disposition (fussiness, crying, gas, spit up, Infant Characteristics Questionnaire) at each study visit | Mean | 20 weeks, 24 weeks |
| Stool microbiome | Fecal microbial taxa and community abundance | 24 weeks |
| Stool metabolome | Targeted and Untargeted Metabolomics | 24 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 |