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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
311
New infant formula for term infants fed ad lib
Commercially available infant formula for term infants fed ad lib
Weight Gain Velocity
G/D
Time frame: up to 24 weeks
Weight Measures
KG
Time frame: 20 weeks, 24 weeks
Length Measures
CM
Time frame: 20 weeks, 24 weeks
Length Gain Velocity
CM/D
Time frame: 20 weeks, 24 weeks
Head Circumference Measures
CM
Time frame: 20 weeks, 24 weeks
Weight for age Z-scores
Weight for age Z-scores compared to World Health Organization (WHO) growth standards
Time frame: 20 weeks, 24 weeks
Length for age Z-scores
Length for age Z-scores compared to WHO growth standards
Time frame: 20 weeks, 24 weeks
Head circumference for age Z-scores
Head circumference for age Z-scores compared to WHO growth standards
Time frame: 20 weeks, 24 weeks
Weight for length Z-scores
Weight for length Z-scores compared to WHO growth standards
Time frame: 20 weeks, 24 weeks
72-hr record of formula intake at each study visit
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Alabama Clinical Therapeutics
Birmingham, Alabama, United States
Watching Over Mothers and Babies
Tucson, Arizona, United States
The Children's Clinic of Jonesboro, P.A.
Jonesboro, Arkansas, United States
Applied Research Center of Arkansas
Little Rock, Arkansas, United States
San Gabriel Women's Health
Arcadia, California, United States
Northern California Research
Sacramento, California, United States
Optum
Colorado Springs, Colorado, United States
Topaz Clinical Research
Apopka, Florida, United States
Sarkis Clinical Trials
Gainesville, Florida, United States
Avanza Medical Research
Pensacola, Florida, United States
...and 17 more locations
oz/d
Time frame: 20 weeks, 24 weeks
Blood concentrations of Interleukin-6 (pg/mL), Interleukin-10 (pg/mL), and tumor necrosis factor-alpha (pg/mL)
Concentration
Time frame: 24 weeks
Blood concentrations of amino acids (umol/L)
Concentration
Time frame: 24 weeks
Human milk composition (concentrations of proteins, lipids, carbohydrates, vitamins, and minerals
Concentration
Time frame: 24 weeks
Medically-diagnosed adverse events collected throughout the study period
Frequency
Time frame: 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 \[no shape, mainly water\]).
Time frame: 20 weeks, 24 weeks
Parent report of infant stool frequency at each study visit
Mean
Time frame: 20 weeks, 24 weeks
Parent report of infant disposition (fussiness, crying, gas, spit up, Infant Characteristics Questionnaire) at each study visit
Mean
Time frame: 20 weeks, 24 weeks
Stool microbiome
Fecal microbial taxa and community abundance
Time frame: 24 weeks
Stool metabolome
Targeted and Untargeted Metabolomics
Time frame: 24 weeks