Growth and Tolerance of a Partially Hydrolyzed Infant Formula

January 22, 2024 updated by: Mead Johnson Nutrition

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
244

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35205
        • Birmingham Pediatric Associates
      • Dothan, Alabama, United States, 36305
        • Southeastern Pediatric Associates
    • Arizona
      • Tucson, Arizona, United States, 85712
        • Visions Clinical Research-Tucson
    • Arkansas
      • Fayetteville, Arkansas, United States, 72703
        • Northwest Arkansas Pediatric Clinic
      • Jonesboro, Arkansas, United States, 72401
        • The Children's Clinic of Jonesboro
    • Florida
      • Tampa, Florida, United States, 33613
        • PAS Research
    • Georgia
      • Union City, Georgia, United States, 30339
        • Rophe Adult & Pediatric Medicine
    • Idaho
      • Nampa, Idaho, United States, 83686
        • Saltzer Health
    • Kentucky
      • Owensboro, Kentucky, United States, 42303
        • Springs Medical Research
    • Nebraska
      • Grand Island, Nebraska, United States, 68803
        • Meridian Clinical Research
    • Tennessee
      • Jackson, Tennessee, United States, 38305
        • The Jackson Clinic
    • Texas
      • Longview, Texas, United States, 75605
        • DCOL Center for Clinical Research
      • McAllen, Texas, United States, 78501
        • PAS Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

1 week to 2 weeks (Child)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: 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
Other: Partially hydrolyzed protein infant formula
A partially hydrolyzed cow's milk protein (PHP) infant formula

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Rate of body weight gain
Time Frame: up to 120 days
up to 120 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Body length
Time Frame: up to 365 days of age
up to 365 days of age
Head circumference
Time Frame: up to 365 days of age
up to 365 days of age
Growth Z scores
Time Frame: up to 365 days of age
weight-for-age
up to 365 days of age
Growth Z scores
Time Frame: up to 365 days of age
length-for-age
up to 365 days of age
Growth Z scores
Time Frame: up to 365 days of age
head circumference-for-age
up to 365 days of age
Recall of study formula intake measured at each study visit
Time Frame: up to 365 days of age
questionnaire
up to 365 days of age
Recall of stool characteristics measured at each study visit
Time Frame: up to 365 days of age
questionnaire
up to 365 days of age
Pediatric Quality of Life Family Impact Module
Time Frame: up to 365 days of age
questionnaire
up to 365 days of age
Pediatric Quality of Life Inventory Infant Scales
Time Frame: 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).
120, 180, 275, and 365 days of age
Medically confirmed adverse events collected throughout the study period
Time Frame: up to 365 days of age
up to 365 days of age
Specific medically confirmed adverse events related to gastrointestinal
Time Frame: up to 365 days of age
up to 365 days of age
Specific medically confirmed adverse events related to allergy
Time Frame: up to 365 days of age
up to 365 days of age
Body weight
Time Frame: up to 365 days of age
up to 365 days of age

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Mead Johnson Nutrition

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Steven Wu, Medical Director, Mead Johnson Nutrition

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 28, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 11, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 21, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 8, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 8, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 17, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 23, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 22, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 3391-1

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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