Clinical trial NCT05047978: Growth and Tolerance of a Partially Hydrolyzed Infant Formula
Official title: Growth and Tolerance of a Partially Hydrolyzed Cow's Milk Protein (PHP) Infant Formula
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Growth
Lead sponsor: Mead Johnson Nutrition
Sponsor class: INDUSTRY
First posted: 2021-09-17
Enrollment: 244
Sex: ALL
Minimum age (years): 10
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Rate of body weight gain
timeFrame: up to 120 days
Secondary outcomes:
measure: Body length
timeFrame: up to 365 days of age
measure: Head circumference
timeFrame: up to 365 days of age
measure: Growth Z scores
timeFrame: up to 365 days of age
measure: Growth Z scores
timeFrame: up to 365 days of age
measure: Growth Z scores
timeFrame: up to 365 days of age
measure: Recall of study formula intake measured at each study visit
timeFrame: up to 365 days of age
measure: Recall of stool characteristics measured at each study visit
timeFrame: up to 365 days of age
measure: Pediatric Quality of Life Family Impact Module
timeFrame: up to 365 days of age
measure: Pediatric Quality of Life Inventory Infant Scales
timeFrame: 120, 180, 275, and 365 days of age
measure: Medically confirmed adverse events collected throughout the study period
timeFrame: up to 365 days of age
measure: Specific medically confirmed adverse events related to gastrointestinal
timeFrame: up to 365 days of age
measure: Specific medically confirmed adverse events related to allergy
timeFrame: up to 365 days of age
measure: Body weight
timeFrame: up to 365 days of age
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Birmingham Pediatric Associates
state: Alabama
city: Dothan
country: United States
facility: Southeastern Pediatric Associates
state: Alabama
city: Tucson
country: United States
facility: Visions Clinical Research-Tucson
state: Arizona
city: Fayetteville
country: United States
facility: Northwest Arkansas Pediatric Clinic
state: Arkansas
city: Jonesboro
country: United States
facility: The Children's Clinic of Jonesboro
state: Arkansas
city: Tampa
country: United States
facility: PAS Research
state: Florida
city: Union City
country: United States
facility: Rophe Adult & Pediatric Medicine
state: Georgia
city: Nampa
country: United States
facility: Saltzer Health
state: Idaho
city: Owensboro
country: United States
facility: Springs Medical Research
state: Kentucky
city: Grand Island
country: United States
facility: Meridian Clinical Research
state: Nebraska
city: Jackson
country: United States
facility: The Jackson Clinic
state: Tennessee
city: Longview
country: United States
facility: DCOL Center for Clinical Research
state: Texas
city: McAllen
country: United States
facility: PAS Research
state: Texas
Study officials:
affiliation: Mead Johnson Nutrition
name: Steven Wu, Medical Director
role: STUDY_DIRECTOR
References: