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Acceptance of a Partially Hydrolyzed Formula
Acceptance of a Partially Hydrolyzed Formula
CompletedNA
Sponsor: Mead Johnson Nutrition
Conditions: Fussy Infant (Baby)
Interventions: Infant Formula - Partially hydrolyzed protein, Infant Formula - Intact protein
Countries: United States
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.
Eligibility overview
Sex: ALL
Age: 15 Days to 75 Days
Healthy volunteers: No
Study type: INTERVENTIONAL
Eligibility criteria
Inclusion Criteria: * 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 Criteria: * 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)
Locations (11)
- Birmingham, Alabama, United States
- Birmingham, Alabama, United States
- Miramar, Florida, United States
- Sarasota, Florida, United States
- Moline, Illinois, United States
- Lincoln, Nebraska, United States
- Charleston, South Carolina, United States
- Greenville, South Carolina, United States
- Memphis, Tennessee, United States
- Del Rio, Texas, United States
- Edinburg, Texas, United States