Acceptance of a Partially Hydrolyzed Formula

Completed · Not applicable

Conditions studied: Fussy Infant (Baby)

In brief

A multi-center, double-blind, controlled, parallel-designed, prospective trial intended to evaluate the nutritive effects of a partially hydrolyzed cow's milk protein infant formula on infant fussiness.

Key facts

Study ID

NCT05245422

Run by

Mead Johnson Nutrition

People needed

148

Starts

2022-02-28

Expected to finish

2023-07-14

Last updated by the study team

2025-06-18

Who can join

Age: 0 and older, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Primary caregiver has reliable access to the internet and a reliable device (such as a computer, tablet, or smartphone) to access mobile apps and be able to view and complete study questionnaires
• Singleton birth
• 15 to 75 days of age at Visit 1, inclusive (day of birth is considered Day 0)
• Gestational age of ≥37 to 42 weeks (36 weeks and six days is considered 36 weeks' gestational age)
• Birth weight of 2500 g (5 lbs 8 oz) or more
• Exclusively receiving an intact protein infant formula (cow's milk-based or plant-based) for 7 days prior to Visit 1
• Answer to question: "On average, how fussy has your baby been over the past 3 days" is moderately fussy, very fussy, or extremely fussy at Visit 1
• Parent(s) or legal guardian has full intention to exclusively feed study formula during the study period
• Parent(s) or legal guardian agrees not to enroll infant in another interventional clinical study while participating in this study
• Signed informed consent obtained from parent or legal guardian for infant's participation in the study
• Signed authorization obtained from parent or legal guardian to use and/or disclose Protected Health Information for infant from birth through the length of the study period

You may not qualify if…

• Infant has been weighed by a health care professional (HCP) and is identified with inadequate weight gain or failure-to-thrive
• Diagnosis or suspicion of cow's milk protein allergy by a healthcare professional
• Any acute illness within the 3 days prior to Visit 1
• Infant has had immunizations or a surgical procedure within the 3 days prior to or on Visit 1
• Immunizations are planned for the infant during any of the 7 days after Visit 1
• Use of oral, intramuscular or intravenous antibiotics within the 7 days prior to Visit 1
• Infant has had bloody stools (visible to the naked eye) within the 7 days prior to Visit 1
• Infant has been taking medication (prescribed and over-the-counter) for gastrointestinal conditions for any of the 7 days prior to Visit 1 (however, probiotics are allowed)
• Infant has a surgical procedure planned during the study period
• History of underlying metabolic or chronic disease; congenital malformation; or any other condition which, in the opinion of the investigator, is likely to interfere with: the ability of the infant to ingest food, the normal growth and development of the infant, or the evaluation of the infant
• History of underlying neurological or organic disease likely to cause fussiness, such as (but not limited to) a doctor's diagnosis of neonatal abstinence syndrome and inflammatory or orthopedic disorders
• Infant is immunocompromised (according to a doctor's diagnosis of immunodeficiency such as combined immunodeficiencies, DiGeorge syndrome, Wiskott-Aldrich syndrome, severe congenital neutropenia and secondary immunodeficiencies linked to HIV infection, Down syndrome or others)

Where it is running

• Birmingham Pediatric Associates — Birmingham, Alabama, United States
• Alabama Clinical Therapeutics — Birmingham, Alabama, United States
• DBC Research USA — Miramar, Florida, United States
• Proactive Clinical Research — Sarasota, Florida, United States
• Mid Valley Research Inc. — Moline, Illinois, United States
• Frontier Pediatric Research — Lincoln, Nebraska, United States
• Meridian Clinical Research — Charleston, South Carolina, United States
• Tribe Clinical Research — Greenville, South Carolina, United States
• AVIATI Healthcare & Clinical Research — Memphis, Tennessee, United States
• South Texas Pediatric Research Group — Del Rio, Texas, United States
• Proactive Clinical Research — Edinburg, Texas, United States

Full record on ClinicalTrials.gov

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