Growth and Tolerance of a Partially Hydrolyzed Infant Formula

• Sponsor: Mead Johnson Nutrition (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05047978
• Collaborator: (none)
• Enrollment: 240
• Locations: 13
• Arms: 2
• Anticipated Duration (Months): 18
• Patients Per Site: 18.5
• Patients Per Site Per Month: 1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Growth	Other: Cow's milk protein infant formula; Other: Partially hydrolyzed protein infant formula	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 240 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Other
• Official Title: Growth and Tolerance of a Partially Hydrolyzed Cow's Milk Protein (PHP) Infant Formula
• Actual Study Start Date: Aug 28, 2021
• Anticipated Primary Completion Date: Jun 28, 2022
• Anticipated Study Completion Date: Feb 28, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: A routine cow's milk-based infant formula A routine cow's milk-based infant formula	Other: Cow's milk protein infant formula; A routine cow's milk-based infant formula
Experimental: A partially hydrolyzed cow's milk protein (PHP) infant formula A partially hydrolyzed cow's milk protein (PHP) infant formula	Other: Partially hydrolyzed protein infant formula; A partially hydrolyzed cow's milk protein (PHP) infant formula

Outcome Measures

Primary Outcome Measures

1. Rate of body weight gain [up to 120 days]

Secondary Outcome Measures

1. Body length [up to 365 days of age]

2. Head circumference [up to 365 days of age]

3. Growth Z scores [up to 365 days of age]

   weight-for-age

4. Growth Z scores [up to 365 days of age]

   length-for-age

5. Growth Z scores [up to 365 days of age]

   head circumference-for-age

6. Recall of study formula intake measured at each study visit [up to 365 days of age]

   questionnaire

7. Recall of stool characteristics measured at each study visit [up to 365 days of age]

   questionnaire

8. Pediatric Quality of Life Family Impact Module [up to 365 days of age]

   questionnaire

9. 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).

10. Medically confirmed adverse events collected throughout the study period [up to 365 days of age]

11. Specific medically confirmed adverse events related to gastrointestinal [up to 365 days of age]

12. Specific medically confirmed adverse events related to allergy [up to 365 days of age]

13. Body weight [up to 365 days of age]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 10 Days to 14 Days
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Birmingham Pediatric Associates	Birmingham	Alabama	United States	35205
2	Southeastern Pediatric Associates	Dothan	Alabama	United States	36305
3	Visions Clinical Research-Tucson	Tucson	Arizona	United States	85712
4	Northwest Arkansas Pediatric Clinic	Fayetteville	Arkansas	United States	72703
5	The Children's Clinic of Jonesboro	Jonesboro	Arkansas	United States	72401
6	PAS Research	Tampa	Florida	United States	33613
7	Rophe Adult & Pediatric Medicine	Union City	Georgia	United States	30339
8	Saltzer Health	Nampa	Idaho	United States	83686
9	Springs Medical Research	Owensboro	Kentucky	United States	42303
10	Meridian Clinical Research	Grand Island	Nebraska	United States	68803
11	The Jackson Clinic	Jackson	Tennessee	United States	38305
12	DCOL Center for Clinical Research	Longview	Texas	United States	75605
13	PAS Research	McAllen	Texas	United States	78501

Sponsors and Collaborators

• Mead Johnson Nutrition

Investigators

• Study Director: Steven Wu, Medical Director, Mead Johnson Nutrition

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Mead Johnson Nutrition
• ClinicalTrials.gov Identifier: NCT05047978
• Other Study ID Numbers: MeadJohnson
• First Posted: Sep 17, 2021
• Last Update Posted: Sep 24, 2021
• Last Verified: Sep 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Caseins

Study Results

No Results Posted as of Sep 24, 2021