Follow-up Study 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 two-month follow-up study is to continue to follow growth, safety, and other health outcomes of infants fed a new infant formula for term infants or comparator formula. A reference group of human milk-fed infants will also be followed. This study is designed in accordance with Good Clinical Practice guidelines.

Official Title
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Follow-up Study of Growth, Safety, and Efficacy of an Infant Formula for Healthy Term Infants

Conditions
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Healthy, Term Infants

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: Subjects who enrolled and completed the previous phase of the clinical trial: NCT04218929 Evaluation of Growth, Safety, and Efficacy of an Infant Formula for Healthy Term Infants Exclusion Criteria: Subjects who did not enroll in the previous phase of the clinical trial: NCT04218929 Evaluation of Growth, Safety, and Efficacy of an Infant Formula for Healthy Term Infants

Ages Eligible for Study
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Minimum Age: 16 Weeks
Maximum Age: 19 Weeks

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>Other: Comparator Formula (CF)<br>* Commercially available infant formula for term infants fed ad lib<br>|
| Active Comparator: Comparator Formula (CF)<br>Commercially available infant formula for term infants | Other: Study Formula (SF)<br>* New infant formula for term infants fed ad lib<br>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 | up to 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight Measures | KG | 20 weeks, 24 weeks | 
| Length Measures | CM | 20 weeks, 24 weeks | 
| Length Gain Velocity | CM/D | 20 weeks, 24 weeks | 
| Head Circumference Measures | CM | 20 weeks, 24 weeks | 
| Weight for age Z-scores | Weight for age Z-scores compared to World Health Organization (WHO) growth standards | 20 weeks, 24 weeks | 
| Length for age Z-scores | Length for age Z-scores compared to WHO growth standards | 20 weeks, 24 weeks | 
| Head circumference for age Z-scores | Head circumference for age Z-scores compared to WHO growth standards | 20 weeks, 24 weeks | 
| Weight for length Z-scores | Weight for length Z-scores compared to WHO growth standards | 20 weeks, 24 weeks | 
| 72-hr record of formula intake at each study visit | oz/d | 20 weeks, 24 weeks | 
| Blood concentrations of Interleukin-6 (pg/mL), Interleukin-10 (pg/mL), and tumor necrosis factor-alpha (pg/mL) | Concentration | 24 weeks | 
| Blood concentrations of amino acids (umol/L) | Concentration | 24 weeks | 
| Human milk composition (concentrations of proteins, lipids, carbohydrates, vitamins, and minerals | Concentration | 24 weeks | 
| Medically-diagnosed adverse events collected throughout the study period | Frequency | 16-24 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]). | 20 weeks, 24 weeks | 
| Parent report of infant stool frequency at each study visit | Mean | 20 weeks, 24 weeks | 
| Parent report of infant disposition (fussiness, crying, gas, spit up, Infant Characteristics Questionnaire) at each study visit | Mean | 20 weeks, 24 weeks | 
| Stool microbiome | Fecal microbial taxa and community abundance | 24 weeks | 
| Stool metabolome | Targeted and Untargeted Metabolomics | 24 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