The purpose of this research study is to compare the growth and tolerance of infants who consume either an infant formula with intact proteins or an infant formula with partially hydrolyzed proteins through approximately 12 months of age.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
244
A routine cow's milk-based infant formula
A partially hydrolyzed cow's milk protein (PHP) infant formula
Birmingham Pediatric Associates
Birmingham, Alabama, United States
Southeastern Pediatric Associates
Dothan, Alabama, United States
Visions Clinical Research-Tucson
Tucson, Arizona, United States
Rate of body weight gain
Time frame: up to 120 days
Body length
Time frame: up to 365 days of age
Head circumference
Time frame: up to 365 days of age
Growth Z scores
weight-for-age
Time frame: up to 365 days of age
Growth Z scores
length-for-age
Time frame: up to 365 days of age
Growth Z scores
head circumference-for-age
Time frame: up to 365 days of age
Recall of study formula intake measured at each study visit
questionnaire
Time frame: up to 365 days of age
Recall of stool characteristics measured at each study visit
questionnaire
Time frame: up to 365 days of age
Pediatric Quality of Life Family Impact Module
questionnaire
Time frame: up to 365 days of age
Pediatric Quality of Life Inventory Infant Scales
Questionnaire. A 5-point response scale is utilized (0 = never a problem; 4 = always a problem). Items are reverse-scored and linearly transformed to a 0-100 scale (0 = 100, 1 = 75, 2 = 50, 3 = 25, 4 = 0), so that higher scores indicate better functioning (less negative impact).
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Northwest Arkansas Pediatric Clinic
Fayetteville, Arkansas, United States
The Children's Clinic of Jonesboro
Jonesboro, Arkansas, United States
PAS Research
Tampa, Florida, United States
Rophe Adult & Pediatric Medicine
Union City, Georgia, United States
Saltzer Health
Nampa, Idaho, United States
Springs Medical Research
Owensboro, Kentucky, United States
Meridian Clinical Research
Grand Island, Nebraska, United States
...and 3 more locations
Time frame: 120, 180, 275, and 365 days of age
Medically confirmed adverse events collected throughout the study period
Time frame: up to 365 days of age
Specific medically confirmed adverse events related to gastrointestinal
Time frame: up to 365 days of age
Specific medically confirmed adverse events related to allergy
Time frame: up to 365 days of age
Body weight
Time frame: up to 365 days of age