An interventional study of Cow's milk protein infant formula and Partially hydrolyzed protein infant formula in Growth, sponsored by Mead Johnson Nutrition. Completed at 13 sites in United States. Open to participants aged 10 Days to 14 Days, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-01-23.
Sponsored by Mead Johnson Nutrition · Not applicable, Interventional, and Other
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.
Mead Johnson Nutrition is the lead sponsor of 56 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
A routine cow's milk-based infant formula
Other: Cow's milk protein infant formula
A partially hydrolyzed cow's milk protein (PHP) infant formula
Other: Partially hydrolyzed protein infant formula
A routine cow's milk-based infant formula
A partially hydrolyzed cow's milk protein (PHP) infant formula
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).
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
This study is completed, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.
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Mead Johnson Nutrition