Growth and Tolerance of a Partially Hydrolyzed Infant Formula

Growth Clinical Trial

Official title:

Growth and Tolerance of a Partially Hydrolyzed Cow's Milk Protein (PHP) Infant Formula

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05047978
• Other study ID #: 3391-1
• Status: Completed
• Phase: N/A
• Start date: August 28, 2021
• Est. completion date: November 21, 2023

Study information

• Verified date: January 2024
• Source: Mead Johnson Nutrition
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 244
• Est. completion date: November 21, 2023
• Est. primary completion date: October 11, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 Days to 14 Days

Eligibility

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

Related Conditions & MeSH terms

• Growth

Intervention

Other:
• Cow's milk protein infant formula
A routine cow's milk-based infant formula
• Partially hydrolyzed protein infant formula
A partially hydrolyzed cow's milk protein (PHP) infant formula

Locations

Country	Name	City	State
United States	Birmingham Pediatric Associates	Birmingham	Alabama
United States	Southeastern Pediatric Associates	Dothan	Alabama
United States	Northwest Arkansas Pediatric Clinic	Fayetteville	Arkansas
United States	Meridian Clinical Research	Grand Island	Nebraska
United States	The Jackson Clinic	Jackson	Tennessee
United States	The Children's Clinic of Jonesboro	Jonesboro	Arkansas
United States	DCOL Center for Clinical Research	Longview	Texas
United States	PAS Research	McAllen	Texas
United States	Saltzer Health	Nampa	Idaho
United States	Springs Medical Research	Owensboro	Kentucky
United States	PAS Research	Tampa	Florida
United States	Visions Clinical Research-Tucson	Tucson	Arizona
United States	Rophe Adult & Pediatric Medicine	Union City	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Mead Johnson Nutrition

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of body weight gain		up to 120 days
Secondary	Body length		up to 365 days of age
Secondary	Head circumference		up to 365 days of age
Secondary	Growth Z scores	weight-for-age	up to 365 days of age
Secondary	Growth Z scores	length-for-age	up to 365 days of age
Secondary	Growth Z scores	head circumference-for-age	up to 365 days of age
Secondary	Recall of study formula intake measured at each study visit	questionnaire	up to 365 days of age
Secondary	Recall of stool characteristics measured at each study visit	questionnaire	up to 365 days of age
Secondary	Pediatric Quality of Life Family Impact Module	questionnaire	up to 365 days of age
Secondary	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).	120, 180, 275, and 365 days of age
Secondary	Medically confirmed adverse events collected throughout the study period		up to 365 days of age
Secondary	Specific medically confirmed adverse events related to gastrointestinal		up to 365 days of age
Secondary	Specific medically confirmed adverse events related to allergy		up to 365 days of age
Secondary	Body weight		up to 365 days of age