Growth and Tolerance of a Partially Hydrolyzed Infant Formula
- Conditions
- Growth
- Interventions
- Other: Partially hydrolyzed protein infant formulaOther: Cow's milk protein infant formula
- Registration Number
- NCT05047978
- Lead Sponsor
- Mead Johnson Nutrition
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 244
- 10 to 14 days of age at randomization
- singleton birth
- Gestational age of 37 to 42 weeks
- Birth weight of 2500 g (5lbs 8oz or more)
- Exclusively receiving infant formula for at least 24 hours prior to randomization
- Parent or legal guardian has full intention to exclusively feed study formula through 120 days of age
- Parent or legal guardian agrees not to enroll infant in another interventional clinical study while participating in this study
- Signed informed consent and authorization to use and disclose Protected Health information
- History of underlying metabolic or chronic disease
- Evidence of feeding difficulties or history of formula intolerance
- Weight at Visit 1 is <98% of birth weight
- Infant was born large for gestational age from a mother who was diabetic at childbirth
- Infant is immunocompromised
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description A partially hydrolyzed cow's milk protein (PHP) infant formula Partially hydrolyzed protein infant formula A partially hydrolyzed cow's milk protein (PHP) infant formula A routine cow's milk-based infant formula Cow's milk protein infant formula A routine cow's milk-based infant formula
- Primary Outcome Measures
Name Time Method Rate of body weight gain up to 120 days
- Secondary Outcome Measures
Name Time Method Body weight up to 365 days of age Recall of stool characteristics measured at each study visit up to 365 days of age questionnaire
Head circumference up to 365 days of age Growth Z scores up to 365 days of age head circumference-for-age
Recall of study formula intake measured at each study visit up to 365 days of age questionnaire
Pediatric Quality of Life Family Impact Module up to 365 days of age questionnaire
Body length up to 365 days of age Specific medically confirmed adverse events related to gastrointestinal up to 365 days of age Specific medically confirmed adverse events related to allergy up to 365 days of age Pediatric Quality of Life Inventory Infant Scales 120, 180, 275, and 365 days of age 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).
Medically confirmed adverse events collected throughout the study period up to 365 days of age
Trial Locations
- Locations (12)
Visions Clinical Research-Tucson
🇺🇸Tucson, Arizona, United States
Northwest Arkansas Pediatric Clinic
🇺🇸Fayetteville, Arkansas, United States
PAS Research
🇺🇸McAllen, Texas, United States
Rophe Adult & Pediatric Medicine
🇺🇸Union City, Georgia, United States
Meridian Clinical Research
🇺🇸Grand Island, Nebraska, United States
DCOL Center for Clinical Research
🇺🇸Longview, Texas, United States
The Jackson Clinic
🇺🇸Jackson, Tennessee, United States
Birmingham Pediatric Associates
🇺🇸Birmingham, Alabama, United States
Southeastern Pediatric Associates
🇺🇸Dothan, Alabama, United States
The Children's Clinic of Jonesboro
🇺🇸Jonesboro, Arkansas, United States
Saltzer Health
🇺🇸Nampa, Idaho, United States
Springs Medical Research
🇺🇸Owensboro, Kentucky, United States