Growth and Tolerance of a Partially Hydrolyzed Infant Formula
NCT ID: NCT05047978
Last Updated: 2024-01-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
244 participants
INTERVENTIONAL
2021-08-28
2023-11-21
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
The Effects of an Infant Formula Containing Hydrolysed Proteins on Growth and Tolerance in Healthy Term Infants
NCT05757323
Tolerance of an Extensively Hydrolyzed Protein Infant Formula Versus a Premature Infant Formula
NCT01987154
The Effects on Growth of a Non-Routine Infant Formula
NCT00655720
Term Infants Fed a Partially Hydrolyzed Whey Protein-Based Formula
NCT04934397
Gastrointestinal Tolerability of a Partially Hydrolyzed Ready-to-feed Infant Formula in Healthy Newborns
NCT05097924
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
OTHER
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
A routine cow's milk-based infant formula
A routine cow's milk-based infant formula
Cow's milk protein infant formula
A routine cow's milk-based infant formula
A partially hydrolyzed cow's milk protein (PHP) infant formula
A partially hydrolyzed cow's milk protein (PHP) infant formula
Partially hydrolyzed protein infant formula
A partially hydrolyzed cow's milk protein (PHP) infant formula
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
10 Days
14 Days
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Mead Johnson Nutrition
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Steven Wu, Medical Director
Role: STUDY_DIRECTOR
Mead Johnson Nutrition
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Birmingham Pediatric Associates
Birmingham, Alabama, United States
Southeastern Pediatric Associates
Dothan, Alabama, United States
Visions Clinical Research-Tucson
Tucson, Arizona, United States
Northwest Arkansas Pediatric Clinic
Fayetteville, Arkansas, United States
The Children's Clinic of Jonesboro
Jonesboro, Arkansas, United States
PAS Research
Tampa, Florida, United States
Rophe Adult & Pediatric Medicine
Union City, Georgia, United States
Saltzer Health
Nampa, Idaho, United States
Springs Medical Research
Owensboro, Kentucky, United States
Meridian Clinical Research
Grand Island, Nebraska, United States
The Jackson Clinic
Jackson, Tennessee, United States
DCOL Center for Clinical Research
Longview, Texas, United States
PAS Research
McAllen, Texas, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
3391-1
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.