Evaluation of Growth, Safety, and Efficacy of an Infant Formula for Healthy Term Infants

Study Overview
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Brief Summary
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The purpose of this study is to demonstrate that a new infant formula for term infants supports age-appropriate growth. This study is designed in accordance with Good Clinical Practice guidelines and the requirements of the Code of Federal Regulations, 21CFR106.96. In this randomized, controlled trial (RCT), healthy, term, formula-fed (FF) infants will be randomized to one of two infant formulas: a standard, commercially-available infant formula for term infants (CF) or the study formula for term infants (SF) for 16 weeks. A reference group of human milk-fed infants will also be enrolled. The primary efficacy objective is to compare the growth of infants randomized to the study infant formula (SF) versus growth of infants randomized to the standard commercial infant formula (CF).

Official Title
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Evaluation of Growth, Safety, and Efficacy of an Infant Formula for Healthy Term Infants

Conditions
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Infants, Newborn

Intervention / Treatment
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* Other: Study Formula (SF)
* Other: Comparator Formula (CF)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Term (no less than 37 weeks, 0 days and less than 42 weeks, 0 days), singleton infant. Birth weight of greater than or equal to 2500 grams. Designated healthy by a physician. Less than or equal to 14 days of age at enrollment. If formula fed, exclusively consuming and tolerating a cow's milk infant formula at enrollment and have a parent who agrees to feed the study formula as a sole source of nutrition for a minimum of 16 weeks. If human milk fed, predominantly consuming and tolerating human milk and have a mother/parent who plans to predominantly feed human milk as sole source of nutrition for a minimum of 16 weeks. Weight for age greater than or equal to 5th percentile and less than or equal to 95th percentile at enrollment. Length for age greater than or equal to 5th percentile and less than or equal to 95th percentile at enrollment. Head circumference for age greater than or equal to 5th percentile and less than or equal to 95th percentile at enrollment. Weight for length greater than or equal to 5th percentile and less than or equal to 95th percentile at enrollment. Not currently receiving and have a parent/guardian who does not plan to give pre- and/or pro-biotics for the full duration of the study. Not currently participating in an interventional clinical trial and have a parent(s) or legal guardian(s) who agree not to enroll the infant in an interventional clinical trial while participating in this trial. Have parent(s) or legal guardian(s) who are capable of completing the written records, questionnaires, and study procedures required by the protocol. Have a parent(s) or legal guardian(s) who have read and voluntarily signed the Institutional Review Board Informed Consent prior to study participation. Exclusion Criteria: Evidence of any anatomic or physiologic condition that would interfere with normal growth, development, or feeding. Infants required to take medications know to influence growth and development. Maternal history with known adverse effects on the fetus and/or the newborn infants. Family history of cow milk protein allergy or soy intolerance/allergy. Infants receiving any amount supplemental human milk with infant formula or visa-versa at time of enrollment. Infants from a multiple birth.

Ages Eligible for Study
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Minimum Age: 0 Days
Maximum Age: 14 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study Formula (SF)<br>New infant formula for term infants | Other: Study Formula (SF)<br>* New infant formula for term infants fed ad lib<br>|
| Active Comparator: Comparator Formula (CF)<br>Commercially available infant formula for term infants | Other: Comparator Formula (CF)<br>* Commercially available infant formula for term infants fed ad lib<br>|
| No Intervention: Human Milk Reference Group<br>Human milk | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight Gain Velocity | G/D | 0 - 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight Measures | KG | 0 - 16 weeks | 
| Length Measures | CM | 0 - 16 weeks | 
| Length Gain Velocity | CM/D | 0 - 16 weeks | 
| Head Circumference Measures | CM | 0 - 16 weeks | 
| Weight for age Z-scores | Weight for age Z-scores compared to World Health Organization (WHO) growth standards | 0 - 16 weeks | 
| Length for age Z-scores | Length for age Z-scores compared to WHO growth standards | 0 - 16 weeks | 
| Head circumference for age Z-scores | Head circumference for age Z-scores compared to WHO growth standards | 0 - 16 weeks | 
| Weight for length Z-scores | Weight for length Z-scores compared to WHO growth standards | 0 - 16 weeks | 
| 72-hr record of formula intake at each study visit | OZ/D | 0 - 16 weeks | 
| Blood concentrations of Interleukin-6 (pg/mL), Interleukin-10 (pg/mL), and tumor necrosis factor-alpha (pg/mL) | Concentration | 16 weeks | 
| Blood concentrations of amino acids (umol/L) | Concentration | 16 weeks | 
| Human milk composition (concentrations of proteins, lipids, carbohydrates, vitamins, and minerals | Concentration | 3 weeks, 7 weeks | 
| Medically-diagnosed adverse events collected throughout the study period | Frequency | 0 through 16 weeks | 
| Parent rating of infant stool consistency at each study visit | Mean. Quinlan et al Likert scale; 0=no bowel movement, 1=hard [dry hard pellets], 2=formed [definite shape, not dry], 3=soft [no definite shape, pasty], 4=loose [no shape, some water], 5=watery [no shape, mainly water]). | 0 - 16 weeks | 
| Parent report of infant stool frequency at each study visit | Mean | 0 - 16 weeks | 
| Parent report of infant disposition (fussiness, crying, gas, spit up, Infant Characteristics Questionnaire) at each study visit | Mean | 0 - 16 weeks | 
| Stool microbiome | Fecal microbial taxa and community abundance | 2 weeks, 16 weeks | 
| Stool metabolome | Targeted and Untargeted Metabolomics | 2 weeks, 16 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Infant, Infant Formula, Healthy Subjects