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| Name | Class |
|---|---|
| Paidion Research, Inc. | INDUSTRY |
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A goal of infant formula development is to mimic human milk (HM) both in nutrient composition as well as physiologic outcomes. investigators have developed an infant formula for term infants that more closely resembles the composition of human milk. The purpose of this study is to demonstrate that this formulation meets nutritional requirements and supports age appropriate growth of healthy term infants.
This study is a randomized, controlled, double-blind, study of healthy term formula fed (FF) infants. FF infants will be randomized to receive either a experimental infant formula, formulated for healthy term infants (BBN) or a commercially available infant formula for healthy term infants (Brand). Infants will consume the formula for a total of 16-weeks; infant growth, serum markers for inflammation and tolerance to the formulas will be assessed throughout the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BBN | Experimental | An experimental Infant Formula, Milk-Based Powder with Iron, for healthy term infants 0 to 12 months of age with high Sn-2 Palmitate, Alpha Lactalbumin and Osteopontin to better mimic human milk. |
|
| Brand | Active Comparator | A Commercially available Infant Formula, for healthy term infants 0 to 12 months of age (Enfamil TM, Milk-Based Powder with Iron) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BBN | Other | BBN to be feed as the sole source of nutrition for 16 weeks to healthy term infants for 16 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Weight gain | g/d | 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Mean stool consistency | 1= watery, 2= runny / soft, 3= musy / soft, 4= formed soft, 5= hard | Monthly for 16 weeks |
| Mean fussiness score | 0= less fussy than normal, 1= about the same level of fussiness as normal, 2= more fussy than normal |
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Inclusion Criteria:
Infants will be eligible to participate if they meet all of the following conditions. At birth the infant must be:
Healthy, term (early term/no less than 37 weeks, 0 days through late term/no greater than 41 weeks, 6 days), singleton infant
Have a birth weight of ≥ 2500 grams
At the time of the baseline/enrollment visit, infants must be:
Designated as healthy by a physician
≤14 days post-natal age (Date of Birth = Day 0)
Weight for age ≥ 5th and ≤ 95th percentile for age according to sex-specific World Health Organization (WHO) growth charts
Length for age ≥ 5th and ≤ 95th percentile for age according to sex-specific World Health Organization (WHO) growth charts
Head circumference for age ≥ 5th and ≤ 95th percentile for age according to sex-specific World Health Organization (WHO) growth charts
Weight for length for age ≥ 5th and ≤ 95th percentile for age according to sex-specific World Health Organization (WHO) growth charts
Exclusively consuming and tolerating a cow's milk infant formula at time of enrollment; only infants whose parent(s) or legal guardian(s) have decided to feed infant formula as the sole soure of nutrition, will be approached for potential study enrollment
Have parent(s) or legal guardian(s) who agree to feed the study formula to the study subject as his/her sole source of nutrition for the duration of the study
Have parent(s) or legal guardian(s) who have read and voluntarily signed an Informed Consent form approved by the Institutional Review Board prior to any participation in the study.
Exclusion Criteria:
Infants will be ineligible if they have any of the following conditions that are judged by a physician to interfere with the infant's normal growth, development, and/or tolerance to an infant formula:
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| Name | Affiliation | Role |
|---|---|---|
| Laurie Dunn, MD | Paidion Research, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alabama Clinical Therapeutics | Birmingham | Alabama | 35235 | United States | ||
| Southeastern Pediatric Associates |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24840511 | Result | Yao M, Lien EL, Capeding MR, Fitzgerald M, Ramanujam K, Yuhas R, Northington R, Lebumfacil J, Wang L, DeRusso PA. Effects of term infant formulas containing high sn-2 palmitate with and without oligofructose on stool composition, stool characteristics, and bifidogenicity. J Pediatr Gastroenterol Nutr. 2014 Oct;59(4):440-8. doi: 10.1097/MPG.0000000000000443. | |
| 41406156 |
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| ID | Term |
|---|---|
| C083544 | lepirudin |
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Formula feed infants will be randomized to receive either a new infant formula formulated for healthy term infants (BBN) or a commercially available infant formula for healthy term infants (Brand). Infants will consume the formula for a total of 16-weeks.
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This study is a randomized, controlled, double-blind, study of healthy term formula fed (FF) infants.
| Brand | Other | Brand to be feed as the sole source of nutrition for 16 weeks to healthy term infants for 16 weeks. |
|
|
| Monthly 16 weeks |
| Mean gassiness score | 0= no gas, 1= slight amount of gas, 2= moderate amout of gas, 3= excessive amount of gas | Monthly 16 weeks |
| Mean interleukin - 6 Concentration | IL - 6 ng/ml | at 16 weeks |
| Mean interleukin - 10 Concentration | IL - 10 pg/ml | at 16 weeks |
| Mean tumor necrosis factor alpha Concentration | TNF - alpha pg/ml | at 16 weeks |
| Dothan |
| Alabama |
| 36305 |
| United States |
| Norwich Pediatric Group | Norwich | Connecticut | 06360 | United States |
| Aventiv Research | Grove City | Ohio | 43123 | United States |
| HMG Pediatrics at Medical Plaza | Bristol | Tennessee | 37620 | United States |
| Jackson Clinic | Jackson | Tennessee | 38305 | United States |
| Fleming SA, Flunkert S, Kvistgaard AS, McGrath J, Glover DK. New infant formulas for healthy term infants: A randomized, controlled, double-blind, multicenter, non-inferiority design safety study. PLoS One. 2025 Dec 17;20(12):e0336689. doi: 10.1371/journal.pone.0336689. eCollection 2025. |