Clinical trial NCT05245422: Acceptance of a Partially Hydrolyzed Formula
Official title: Parent And Infant Relief (PAIR): Acceptance of a Partially Hydrolyzed Formula
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fussy Infant (Baby)
Lead sponsor: Mead Johnson Nutrition
Sponsor class: INDUSTRY
First posted: 2022-02-18
Enrollment: 148
Sex: ALL
Minimum age (years): 15
Maximum age (years): 75
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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)

Primary outcomes:
measure: Fussiness
timeFrame: Study Feeding Days 1 through 7
Secondary outcomes:
measure: Fussiness
timeFrame: Study Feeding Days 8-28
measure: Gassiness
timeFrame: Study Feeding Days 1-28
measure: Crying
timeFrame: Study Feeding Days 1-28
measure: Spit-up
timeFrame: Study Feeding Days 1-28
measure: Sleep
timeFrame: Study Feeding Days 1-28
measure: Stool frequency
timeFrame: Study Feeding Days 1-28
measure: Stool consistency
timeFrame: Study Feeding Days 1-28
measure: Study Formula Intake
timeFrame: Study Feeding Day 7 and Study Feeding Day 25 (+3 days)
measure: Brief Infant Sleep Questionnaire
timeFrame: Study Feeding Day 14 (+2 days) and Study Feeding Day 25 (+ 3 days)
measure: Quality of Life Questionnaire
timeFrame: Study Feeding Day 7 (+2 days) and Study Feeding Day 25 (+3 days)
measure: Medically confirmed adverse events
timeFrame: Day 1 through end of feeding
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Birmingham Pediatric Associates
state: Alabama
city: Birmingham
country: United States
facility: Alabama Clinical Therapeutics
state: Alabama
city: Miramar
country: United States
facility: DBC Research USA
state: Florida
city: Sarasota
country: United States
facility: Proactive Clinical Research
state: Florida
city: Moline
country: United States
facility: Mid Valley Research Inc.
state: Illinois
city: Lincoln
country: United States
facility: Frontier Pediatric Research
state: Nebraska
city: Charleston
country: United States
facility: Meridian Clinical Research
state: South Carolina
city: Greenville
country: United States
facility: Tribe Clinical Research
state: South Carolina
city: Memphis
country: United States
facility: AVIATI Healthcare & Clinical Research
state: Tennessee
city: Del Rio
country: United States
facility: South Texas Pediatric Research Group
state: Texas
city: Edinburg
country: United States
facility: Proactive Clinical Research
state: Texas
Study officials:
References: