Acceptance of a Partially Hydrolyzed Formula

Study Overview
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Brief Summary
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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
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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.

Official Title
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Parent And Infant Relief (PAIR): Acceptance of a Partially Hydrolyzed Formula

Conditions
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Fussy Infant (Baby)

Intervention / Treatment
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* Other: Infant Formula - Partially hydrolyzed protein
* Other: Infant Formula - Intact protein


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 15 Days
Maximum Age: 75 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cow's milk intact protein infant formula<br>Control | Other: Infant Formula - Intact protein<br>* Intact cow's milk protein<br>|
| Experimental: Partially hydrolyzed cow's milk protein infant formula<br>Investigational | Other: Infant Formula - Partially hydrolyzed protein<br>* Partially hydrolyzed cow's milk protein<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fussiness | Daily Diary | Study Feeding Days 1 through 7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fussiness | Daily Diary | Study Feeding Days 8-28 | 
| Gassiness | Daily Diary | Study Feeding Days 8-28 | 
| Crying | Daily Diary | Study Feeding Days 8-28 | 
| Spit-up | Daily Diary | Study Feeding Days 8-28 | 
| Sleep | Daily Diary | Study Feeding Days 8-28 | 
| Stool frequency | Daily Diary | Study Feeding Days 8-28 | 
| Stool consistency | Daily Diary | Study Feeding Days 8-28 | 
| Study Formula Intake | 24-hour Recall of Study Formula Intake | Study Feeding Day 7 and Study Feeding Day 25 (+3 days) | 
| Brief Infant Sleep Questionnaire | Revised Short Form (BISQ-R SF) | Study Feeding Day 14 (+2 days) and Study Feeding Day 25 (+ 3 days) | 
| Quality of Life Questionnaire | Pediatric Quality of Life Inventory™ Family Impact Module (PedsQL FIM)-Acute | Study Feeding Day 7 (+2 days) and Study Feeding Day 25 (+3 days) | 
| Medically confirmed adverse events | Collected from medical records | Day 1 through end of feeding |