Healthy, Term Infants
Conditions
Keywords
Infant, Infant Formula, Healthy Subjects
Brief summary
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.
Interventions
OTHERStudy Formula (SF)
New infant formula for term infants fed ad lib
Commercially available infant formula for term infants fed ad lib
Sponsors
Paidion Research, Inc.
ByHeart
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
16 Weeks to 19 Weeks
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Weight Gain Velocity | up to 24 weeks | G/D |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length Measures | 20 weeks, 24 weeks | CM |
| Length Gain Velocity | 20 weeks, 24 weeks | CM/D |
| Head Circumference Measures | 20 weeks, 24 weeks | CM |
| Weight for age Z-scores | 20 weeks, 24 weeks | Weight for age Z-scores compared to World Health Organization (WHO) growth standards |
| Length for age Z-scores | 20 weeks, 24 weeks | Length for age Z-scores compared to WHO growth standards |
| Head circumference for age Z-scores | 20 weeks, 24 weeks | Head circumference for age Z-scores compared to WHO growth standards |
| Weight for length Z-scores | 20 weeks, 24 weeks | Weight for length Z-scores compared to WHO growth standards |
| 72-hr record of formula intake at each study visit | 20 weeks, 24 weeks | oz/d |
| Weight Measures | 20 weeks, 24 weeks | KG |
| Blood concentrations of amino acids (umol/L) | 24 weeks | Concentration |
| Human milk composition (concentrations of proteins, lipids, carbohydrates, vitamins, and minerals | 24 weeks | Concentration |
| Medically-diagnosed adverse events collected throughout the study period | 16-24 weeks | Frequency |
| Parent rating of infant stool consistency at each study visit | 20 weeks, 24 weeks | 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 \[no shape, mainly water\]). |
| Parent report of infant stool frequency at each study visit | 20 weeks, 24 weeks | Mean |
| Parent report of infant disposition (fussiness, crying, gas, spit up, Infant Characteristics Questionnaire) at each study visit | 20 weeks, 24 weeks | Mean |
| Stool microbiome | 24 weeks | Fecal microbial taxa and community abundance |
| Stool metabolome | 24 weeks | Targeted and Untargeted Metabolomics |
| Blood concentrations of Interleukin-6 (pg/mL), Interleukin-10 (pg/mL), and tumor necrosis factor-alpha (pg/mL) | 24 weeks | Concentration |
Countries
United States
Outcome results
None listed