Clinical trial NCT05369494: Infants Fed a Hydrolyzed Infant Formula
Official title: Tolerance of Infants Fed a Hydrolyzed Infant Formula
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastrointestinal Tolerance
Lead sponsor: Abbott Nutrition
Sponsor class: INDUSTRY
First posted: 2022-05-11
Enrollment: 33
Sex: ALL
Minimum age (years): 0
Maximum age (years): 90
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The purpose of this non-randomized, multi-center study is to evaluate the growth, tolerance and compliance of an extensively hydrolyzed infant formula in an intended use population of infants.


Eligibility criteria: Inclusion Criteria:

* Infant is 0 to 90 days of age at enrollment.
* Formula-fed Infant who is either experiencing persistent feeding intolerance, symptoms of suspected food protein allergy or currently consuming an extensively hydrolyzed formula (EHF) for symptoms of suspected food protein allergy, persistent feeding intolerance symptoms or other conditions where EHF is deemed an appropriate feeding by their health care professional
* Parent(s) of infants confirm their intention not to administer prescription medications, OTC medications, home remedies, prebiotics, probiotics, herbal preparations or rehydration fluids that might affect GI tolerance, unless their infants are currently consuming and have been directed by their healthcare professional to continue their use during the study
* Parent(s) confirm their intention to feed their infant the study product as the sole source of nutrition for the duration of the study.
* Parent(s) confirm their intention not to administer solid foods or juices to their infant from enrollment through the duration of the study
* Parent(s) confirm their intention not to administer vitamin or mineral supplements (with the exception of Vitamin D supplements) to their infant from enrollment through the duration of the study, unless instructed otherwise by their healthcare professional
* Infant's parent(s) or a LAR has voluntarily signed and dated an informed consent form (ICF) approved by an Independent Ethics Committee/Institutional Review Board (IEC/IRB) and provided Health Insurance Portability and Accountability Act (HIPAA) (or other applicable privacy regulation) authorization prior to any participation in the study

Exclusion Criteria:

* An adverse maternal, fetal or participant medical history that is thought by the investigator to have potential for effects on growth, and/or development
* Awareness of a positive drug screen in the mother or participant
* Suspected maternal substance abuse including alcohol
* Participation in another study that has not been approved as a concomitant study by AN
* Participant is receiving oral or inhaled steroids
* Participant has an allergy or intolerance to any ingredient in the study product, as reported by the parent
* Participant has received an amino acid-based formula

Primary outcomes:
measure: Weight Maintenance
timeFrame: Study Day1 to Study Day 28
Secondary outcomes:
measure: Gastrointestinal Tolerance
timeFrame: Study Day1 to Study Day 28
measure: Weight
timeFrame: Study Day1 to Study Day 28
measure: Length
timeFrame: Study Day1 to Study Day 28
Other outcomes:
measure: Parent Perspectives Questionnaire
timeFrame: Study Day1 to Study Day 28
measure: Formula Satisfaction Questionnaire
timeFrame: Study Day1 to Study Day 28
measure: Infant Feeding and Stool Patterns Questionnaire
timeFrame: Study Day1 to Study Day 28
measure: Health Care Utilization
timeFrame: Study Day1 to Study Day 28
measure: Adverse Events
timeFrame: Study Day1 to Study Day 28
Locations:
city: Washington
country: United States
facility: Meridian Clinical Research, LLC
state: District of Columbia
city: Orange City
country: United States
facility: AdventHealth Medical Group Pediatrics
state: Florida
city: Fayetteville
country: United States
facility: Javara Inc.
state: Georgia
city: Macon
country: United States
facility: Meridian Clinical Research 3259
state: Georgia
city: Owensboro
country: United States
facility: Springs Medical Research
state: Kentucky
city: Charleston
country: United States
facility: Meridian Clinical Research 3357
state: South Carolina
city: Houston
country: United States
facility: Gentle Pediatrics
state: Texas
Study officials:
affiliation: Abbott Nutrition
name: Carlett Ramirez
role: STUDY_CHAIR
References: