Status:
COMPLETED
Acceptance of a Partially Hydrolyzed Formula
Lead Sponsor:
Mead Johnson Nutrition
Conditions:
Fussy Infant (Baby)
Eligibility:
All Genders
15-75 years
Phase:
NA
Brief Summary
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 fussines...
Detailed Description
A multi-center, double-blind, controlled, parallel-designed, prospective trial intended to evaluate the nutritive effects of a partially hydrolyzed cow's milk protein (PHP) infant formula on infant fu...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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)
Key Trial Info
Start Date :
February 28 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 14 2023
Estimated Enrollment :
148 Patients enrolled
Trial Details
Trial ID
NCT05245422
Start Date
February 28 2022
End Date
July 14 2023
Last Update
June 18 2025
Active Locations (11)
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1
Birmingham Pediatric Associates
Birmingham, Alabama, United States, 35205
2
Alabama Clinical Therapeutics
Birmingham, Alabama, United States, 35235
3
DBC Research USA
Miramar, Florida, United States, 33025
4
Proactive Clinical Research
Sarasota, Florida, United States, 34243