- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03331276
Growth and Safety Study of an Infant Formula for Healthy Term Infants
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Alabama
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Birmingham, Alabama, United States, 35235
- Alabama Clinical Therapeutics
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Dothan, Alabama, United States, 36305
- Southeastern Pediatric Associates
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Connecticut
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Norwich, Connecticut, United States, 06360
- Norwich Pediatric Group
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Ohio
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Grove City, Ohio, United States, 43123
- Aventiv Research
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Tennessee
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Bristol, Tennessee, United States, 37620
- HMG Pediatrics at Medical Plaza
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Jackson, Tennessee, United States, 38305
- Jackson Clinic
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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:
- 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.) -
Study Plan
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: BBN
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.
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BBN to be feed as the sole source of nutrition for 16 weeks to healthy term infants for 16 weeks.
Other Names:
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ACTIVE_COMPARATOR: Brand
A Commercially available Infant Formula, for healthy term infants 0 to 12 months of age (Enfamil TM, Milk-Based Powder with Iron)
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Brand to be feed as the sole source of nutrition for 16 weeks to healthy term infants for 16 weeks.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Weight gain
Time Frame: 16 weeks
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g/d
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16 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean stool consistency
Time Frame: Monthly for 16 weeks
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1= watery, 2= runny / soft, 3= musy / soft, 4= formed soft, 5= hard
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Monthly for 16 weeks
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Mean fussiness score
Time Frame: Monthly 16 weeks
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0= less fussy than normal, 1= about the same level of fussiness as normal, 2= more fussy than normal
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Monthly 16 weeks
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Mean gassiness score
Time Frame: Monthly 16 weeks
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0= no gas, 1= slight amount of gas, 2= moderate amout of gas, 3= excessive amount of gas
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Monthly 16 weeks
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Mean interleukin - 6 Concentration
Time Frame: at 16 weeks
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IL - 6 ng/ml
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at 16 weeks
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Mean interleukin - 10 Concentration
Time Frame: at 16 weeks
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IL - 10 pg/ml
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at 16 weeks
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Mean tumor necrosis factor alpha Concentration
Time Frame: at 16 weeks
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TNF - alpha pg/ml
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at 16 weeks
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Laurie Dunn, MD, Paidion Research, Inc.
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- BBN-IF-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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