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Growth and Safety Study of an Infant Formula for Healthy Term Infants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03331276
Recruitment Status : Completed
First Posted : November 6, 2017
Last Update Posted : October 15, 2020
Sponsor:
Collaborator:
Paidion Research, Inc.
Information provided by (Responsible Party):
Building Block Nutritionals, LLC

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Infant Development Other: BBN Other: Brand Not Applicable

Detailed Description:
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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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 260 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: This study is a randomized, controlled, double-blind, study of healthy term formula fed (FF) infants.
Primary Purpose: Other
Official Title: Growth and Safety Study of an Infant Formula for Healthy Term Infants
Actual Study Start Date : September 18, 2017
Actual Primary Completion Date : January 7, 2019
Actual Study Completion Date : January 7, 2019

Resource links provided by the National Library of Medicine


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.
Other: BBN
BBN to be feed as the sole source of nutrition for 16 weeks to healthy term infants for 16 weeks.
Other Name: BBN-001

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)
Other: Brand
Brand to be feed as the sole source of nutrition for 16 weeks to healthy term infants for 16 weeks.
Other Name: Enfamil




Primary Outcome Measures :
  1. Weight gain [ Time Frame: 16 weeks ]
    g/d


Secondary Outcome Measures :
  1. Mean stool consistency [ Time Frame: Monthly for 16 weeks ]
    1= watery, 2= runny / soft, 3= musy / soft, 4= formed soft, 5= hard

  2. Mean fussiness score [ Time Frame: Monthly 16 weeks ]
    0= less fussy than normal, 1= about the same level of fussiness as normal, 2= more fussy than normal

  3. Mean gassiness score [ Time Frame: Monthly 16 weeks ]
    0= no gas, 1= slight amount of gas, 2= moderate amout of gas, 3= excessive amount of gas

  4. Mean interleukin - 6 Concentration [ Time Frame: at 16 weeks ]
    IL - 6 ng/ml

  5. Mean interleukin - 10 Concentration [ Time Frame: at 16 weeks ]
    IL - 10 pg/ml

  6. Mean tumor necrosis factor alpha Concentration [ Time Frame: at 16 weeks ]
    TNF - alpha pg/ml



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 14 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Infants will be eligible to participate if they meet all of the following conditions. At birth the infant must be:

    1. Healthy, term (early term/no less than 37 weeks, 0 days through late term/no greater than 41 weeks, 6 days), singleton infant
    2. Have a birth weight of ≥ 2500 grams

      At the time of the baseline/enrollment visit, infants must be:

    3. Designated as healthy by a physician
    4. ≤14 days post-natal age (Date of Birth = Day 0)
    5. Weight for age ≥ 5th and ≤ 95th percentile for age according to sex-specific World Health Organization (WHO) growth charts
    6. Length for age ≥ 5th and ≤ 95th percentile for age according to sex-specific World Health Organization (WHO) growth charts
    7. Head circumference for age ≥ 5th and ≤ 95th percentile for age according to sex-specific World Health Organization (WHO) growth charts
    8. Weight for length for age ≥ 5th and ≤ 95th percentile for age according to sex-specific World Health Organization (WHO) growth charts
    9. 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
    10. 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
    11. 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:

  1. Show evidence of anatomic and physiologic defects of the respiratory tract, or other congenital defects (as determined by the clinician);
  2. Show evidence of chronic hepatic, gastrointestinal, renal, cardiac, pulmonary, or neurological diseases;
  3. 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
  4. Have a family history of cow's milk protein intolerance/allergy
  5. Are an infant from a multiple birth (twin, triplet, etc.) -

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03331276


Locations
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United States, Alabama
Alabama Clinical Therapeutics
Birmingham, Alabama, United States, 35235
Southeastern Pediatric Associates
Dothan, Alabama, United States, 36305
United States, Connecticut
Norwich Pediatric Group
Norwich, Connecticut, United States, 06360
United States, Ohio
Aventiv Research
Grove City, Ohio, United States, 43123
United States, Tennessee
HMG Pediatrics at Medical Plaza
Bristol, Tennessee, United States, 37620
Jackson Clinic
Jackson, Tennessee, United States, 38305
Sponsors and Collaborators
Building Block Nutritionals, LLC
Paidion Research, Inc.
Investigators
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Study Director: Laurie Dunn, MD Paidion Research, Inc.
Publications of Results:
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Responsible Party: Building Block Nutritionals, LLC
ClinicalTrials.gov Identifier: NCT03331276    
Other Study ID Numbers: BBN-IF-001
First Posted: November 6, 2017    Key Record Dates
Last Update Posted: October 15, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No