Fussy Infant (Baby)
Conditions
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 fussiness.
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 fussiness. Formula tolerance and intake, sleep characteristics, stool characteristics, parental quality of life, and medically confirmed adverse events will be compared between i two study groups.
Interventions
OTHERInfant Formula - Partially hydrolyzed protein
Partially hydrolyzed cow's milk protein
OTHERInfant Formula - Intact protein
Intact cow's milk protein
Sponsors
Mead Johnson Nutrition
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
15 Days to 75 Days
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fussiness | Study Feeding Days 1 through 7 | Daily Diary |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fussiness | Study Feeding Days 8-28 | Daily Diary |
| Gassiness | Study Feeding Days 1-28 | Daily Diary |
| Crying | Study Feeding Days 1-28 | Daily Diary |
| Spit-up | Study Feeding Days 1-28 | Daily Diary |
| Sleep | Study Feeding Days 1-28 | Daily Diary |
| Stool frequency | Study Feeding Days 1-28 | Daily Diary |
| Stool consistency | Study Feeding Days 1-28 | Daily Diary |
| Study Formula Intake | Study Feeding Day 7 and Study Feeding Day 25 (+3 days) | 24-hour Recall of Study Formula Intake |
| Brief Infant Sleep Questionnaire | Study Feeding Day 14 (+2 days) and Study Feeding Day 25 (+ 3 days) | Revised Short Form (BISQ-R SF) |
| Quality of Life Questionnaire | Study Feeding Day 7 (+2 days) and Study Feeding Day 25 (+3 days) | Pediatric Quality of Life Inventory™ Family Impact Module (PedsQL FIM)-Acute |
| Medically confirmed adverse events | Day 1 through end of feeding | Collected from medical records |
Countries
United States
Outcome results
None listed