Phase II Growth and Safety Study of an Infant Formula for Healthy Term Infants
NCT ID: NCT04593147
Last Updated: 2021-11-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
131 participants
INTERVENTIONAL
2020-10-14
2021-11-09
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
QUADRUPLE
Study Groups
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BBN
An experimental Infant Formula, Milk-Based Powder with Iron, for healthy term infants 0 to 12 months of age with Sn-2 Palmitate, Alpha Lactalbumin and Lactoferrin to better mimic human milk.
BBN
BBN to be fed as the sole source of nutrition for 16 weeks to healthy term infants for 16 weeks.
Brand
A commercially available Infant Formula, for healthy term infants 0 to 2 months of age (Enfamil TM, Milk-Based Powder with Iron).
Brand
Brand to be fed as the sole source of nutrition for 16 weeks to healthy term infants for 16 weeks
Interventions
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BBN
BBN to be fed as the sole source of nutrition for 16 weeks to healthy term infants for 16 weeks.
Brand
Brand to be fed as the sole source of nutrition for 16 weeks to healthy term infants for 16 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Have a birth weight of ≥ 2500 grams
* 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 source 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.
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:
Exclusion Criteria
* Show evidence of anatomic and physiologic defects of the respiratory tract, or other congenital defects (as determined by the clinician);
* Show evidence of chronic hepatic, gastrointestinal, renal, cardiac, pulmonary, or neurological diseases;
* Have a maternal history with known adverse effects on the fetus and/or the newborn infant, such as diabetes (gestational diabetes is acceptable if infant's birth weight is \< 4300 g), active tuberculosis, perinatal infection, or substance abuse
* Have a family history of cow's milk protein intolerance/allergy
* Are an infant from a multiple birth (twin, triplet, etc.)
1 Day
14 Days
ALL
Yes
Sponsors
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Paidion Research, Inc.
INDUSTRY
Building Block Nutritionals, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Kumar Ilangovan, MD
Role: STUDY_DIRECTOR
Medical Monitor
Locations
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PAS Research
Tampa, Florida, United States
Countries
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References
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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.
Other Identifiers
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Phase II BBN-IF-001
Identifier Type: -
Identifier Source: org_study_id