Acceptance of a Partially Hydrolyzed Formula

Fussy Infant (Baby) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05245422
• Other study ID #: 3392-1
• Status: Completed
• Phase: N/A
• Start date: February 28, 2022
• Est. completion date: July 14, 2023

Study information

• Verified date: July 2023
• Source: Mead Johnson Nutrition
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 148
• Est. completion date: July 14, 2023
• Est. primary completion date: July 14, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Days to 75 Days

Eligibility

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)

Related Conditions & MeSH terms

• Fussy Infant (Baby)

Intervention

Other:
• Infant Formula - Partially hydrolyzed protein
Partially hydrolyzed cow's milk protein
• Infant Formula - Intact protein
Intact cow's milk protein

Locations

Country	Name	City	State
United States	Alabama Clinical Therapeutics	Birmingham	Alabama
United States	Birmingham Pediatric Associates	Birmingham	Alabama
United States	Meridian Clinical Research	Charleston	South Carolina
United States	South Texas Pediatric Research Group	Del Rio	Texas
United States	Proactive Clinical Research	Edinburg	Texas
United States	Tribe Clinical Research	Greenville	South Carolina
United States	Frontier Pediatric Research	Lincoln	Nebraska
United States	AVIATI Healthcare & Clinical Research	Memphis	Tennessee
United States	DBC Research USA	Miramar	Florida
United States	Mid Valley Research Inc.	Moline	Illinois
United States	Proactive Clinical Research	Sarasota	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Mead Johnson Nutrition

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fussiness	Daily Diary	Study Feeding Days 1 through 7
Secondary	Fussiness	Daily Diary	Study Feeding Days 8-28
Secondary	Gassiness	Daily Diary	Study Feeding Days 8-28
Secondary	Crying	Daily Diary	Study Feeding Days 8-28
Secondary	Spit-up	Daily Diary	Study Feeding Days 8-28
Secondary	Sleep	Daily Diary	Study Feeding Days 8-28
Secondary	Stool frequency	Daily Diary	Study Feeding Days 8-28
Secondary	Stool consistency	Daily Diary	Study Feeding Days 8-28
Secondary	Study Formula Intake	24-hour Recall of Study Formula Intake	Study Feeding Day 7 and Study Feeding Day 25 (+3 days)
Secondary	Brief Infant Sleep Questionnaire	Revised Short Form (BISQ-R SF)	Study Feeding Day 14 (+2 days) and Study Feeding Day 25 (+ 3 days)
Secondary	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)
Secondary	Medically confirmed adverse events	Collected from medical records	Day 1 through end of feeding