NCT05047978

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
244

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2021

Typical duration for not_applicable

Geographic Reach
1 country

13 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 28, 2021

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

September 8, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 17, 2021

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 11, 2022

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 21, 2023

Completed
Last Updated

January 23, 2024

Status Verified

January 1, 2024

Enrollment Period

1.1 years

First QC Date

September 8, 2021

Last Update Submit

January 22, 2024

Conditions

Growth

Outcome Measures

Primary Outcomes (1)

  • Rate of body weight gain

    up to 120 days

Secondary Outcomes (13)

  • Body length

    up to 365 days of age

  • Head circumference

    up to 365 days of age

  • Growth Z scores

    up to 365 days of age

  • Growth Z scores

    up to 365 days of age

  • Growth Z scores

    up to 365 days of age

  • +8 more secondary outcomes

Study Arms (2)

A routine cow's milk-based infant formula

ACTIVE COMPARATOR

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

EXPERIMENTAL

A partially hydrolyzed cow's milk protein (PHP) infant formula

Other: Partially hydrolyzed protein infant formula

Interventions

Cow's milk protein infant formulaOTHER

A routine cow's milk-based infant formula

A routine cow's milk-based infant formula
Partially hydrolyzed protein infant formulaOTHER

A partially hydrolyzed cow's milk protein (PHP) infant formula

A partially hydrolyzed cow's milk protein (PHP) infant formula

Eligibility Criteria

Age10 Days - 14 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Birmingham Pediatric Associates

Birmingham, Alabama, 35205, United States

Location

Southeastern Pediatric Associates

Dothan, Alabama, 36305, United States

Location

Visions Clinical Research-Tucson

Tucson, Arizona, 85712, United States

Location

Northwest Arkansas Pediatric Clinic

Fayetteville, Arkansas, 72703, United States

Location

The Children's Clinic of Jonesboro

Jonesboro, Arkansas, 72401, United States

Location

PAS Research

Tampa, Florida, 33613, United States

Location

Rophe Adult & Pediatric Medicine

Union City, Georgia, 30339, United States

Location

Saltzer Health

Nampa, Idaho, 83686, United States

Location

Springs Medical Research

Owensboro, Kentucky, 42303, United States

Location

Meridian Clinical Research

Grand Island, Nebraska, 68803, United States

Location

The Jackson Clinic

Jackson, Tennessee, 38305, United States

Location

DCOL Center for Clinical Research

Longview, Texas, 75605, United States

Location

PAS Research

McAllen, Texas, 78501, United States

Location

Related Publications (1)

  • Fabrizio V, Abdelmagid SA, Bose A, Hale M, Hays EC, Hudson M, Hughes T, Leonard D, Rouse K, Sideri M, Walker J, Wampler JL, Yeiser M, Zhuang W, Wu SS. Partially hydrolyzed cow's milk protein formula with an added prebiotic is well-tolerated, safe, and supports age-appropriate growth in healthy term infants through one year of age: DBRCT. BMC Pediatr. 2026 Jan 13. doi: 10.1186/s12887-025-06454-2. Online ahead of print.

    PMID: 41527066DERIVED

Study Officials

  • Steven Wu, Medical Director

    Mead Johnson Nutrition

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 8, 2021

First Posted

September 17, 2021

Study Start

August 28, 2021

Primary Completion

October 11, 2022

Study Completion

November 21, 2023

Last Updated

January 23, 2024

Record last verified: 2024-01

Locations

US(13)