Status:
COMPLETED
Growth and Safety Study of an Infant Formula for Healthy Term Infants
Lead Sponsor:
Building Block Nutritionals, LLC
Collaborating Sponsors:
Paidion Research, Inc.
Conditions:
Infant Development
Eligibility:
All Genders
1-14 years
Phase:
NA
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...
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 heal...
Eligibility Criteria
Inclusion
- 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
- 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.) -
Key Trial Info
Start Date :
September 18 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 7 2019
Estimated Enrollment :
260 Patients enrolled
Trial Details
Trial ID
NCT03331276
Start Date
September 18 2017
End Date
January 7 2019
Last Update
October 19 2020
Active Locations (6)
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1
Alabama Clinical Therapeutics
Birmingham, Alabama, United States, 35235
2
Southeastern Pediatric Associates
Dothan, Alabama, United States, 36305
3
Norwich Pediatric Group
Norwich, Connecticut, United States, 06360
4
Aventiv Research
Grove City, Ohio, United States, 43123