Acceptance of a Partially Hydrolyzed Formula
- Conditions
- Fussy Infant (Baby)
- Interventions
- Other: Infant Formula - Partially hydrolyzed proteinOther: Infant Formula - Intact protein
- Registration Number
- NCT05245422
- Lead Sponsor
- Mead Johnson Nutrition
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 148
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Partially hydrolyzed cow's milk protein infant formula Infant Formula - Partially hydrolyzed protein Investigational Cow's milk intact protein infant formula Infant Formula - Intact protein Control
- Primary Outcome Measures
Name Time Method Fussiness Study Feeding Days 1 through 7 Daily Diary
- Secondary Outcome Measures
Name Time Method Stool frequency Study Feeding Days 8-28 Daily Diary
Stool consistency Study Feeding Days 8-28 Daily Diary
Gassiness Study Feeding Days 8-28 Daily Diary
Crying Study Feeding Days 8-28 Daily Diary
Spit-up Study Feeding Days 8-28 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)
Fussiness Study Feeding Days 8-28 Daily Diary
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
Sleep Study Feeding Days 8-28 Daily Diary
Trial Locations
- Locations (10)
Mid Valley Research Inc.
🇺🇸Moline, Illinois, United States
Birmingham Pediatric Associates
🇺🇸Birmingham, Alabama, United States
DBC Research USA
🇺🇸Miramar, Florida, United States
Alabama Clinical Therapeutics
🇺🇸Birmingham, Alabama, United States
Proactive Clinical Research
🇺🇸Edinburg, Texas, 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
Frontier Pediatric Research
🇺🇸Lincoln, Nebraska, United States
Meridian Clinical Research
🇺🇸Charleston, South Carolina, United States