Clinical trial NCT04006236: Infants Fed Extensively Hydrolyzed Casein-Based Infant Formulas
Official title: Growth and Tolerance of Infants Fed Extensively Hydrolyzed Casein-Based Infant Formulas
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infant Development
Lead sponsor: Abbott Nutrition
Sponsor class: INDUSTRY
First posted: 2019-07-05
Enrollment: 245
Sex: ALL
Minimum age (years): 0
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This is a randomized, controlled, double-blind, multicenter parallel study to evaluate the growth, tolerance and compliance of healthy infants fed infant formulas with extensively hydrolyzed casein protein.


Eligibility criteria: Inclusion Criteria:

* Participant is judged to be in good health
* Participant is a singleton from a full-term birth with a gestational age of 37-42 weeks
* Participant's birth weight was \> 2490 g (\~5 lbs. 8 oz.)
* 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 vitamins, minerals (with the exception of Vitamin D supplements), solid foods or juices to their infant from enrollment throughout the duration of the study
* Participant's parent(s) 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

Exclusion Criteria:

* An adverse maternal, fetal or participant medical history that is thought by the investigator to have potential for effects on tolerance, growth, and/or development.
* Participant is taking and plans to continue taking medications, home remedies, prebiotics, probiotics, herbal preparations or rehydration fluids that might affect gastrointestinal (GI) tolerance
* Participant participates in another study that has not been approved as a concomitant study by AN.
* Participant has an allergy or intolerance to any ingredient in the study product
* Participant has been treated with antibiotics within 1 week prior to enrollment

Primary outcomes:
measure: Weight
timeFrame: Day of Age (DOA) 14 to 119
Secondary outcomes:
measure: Length
timeFrame: Study Day (SD) 1 to DOA 119
measure: Head Circumference
timeFrame: Study Day (SD) 1 to DOA 119
measure: Stool Characteristics
timeFrame: Study Day (SD) 1 to DOA 119
measure: Formula Intake
timeFrame: Study Day (SD) 1 to DOA 119
Other outcomes:
measure: Infant Feeding and Stool Patterns Questionnaire
timeFrame: Exit or DOA 119
measure: Infant Behavior Questionnaire
timeFrame: Exit or DOA 119
measure: Formula Satisfaction Questionnaire
timeFrame: Exit or DOA 119
Locations:
city: Phoenix
country: United States
facility: MedPharmics, LLC
state: Arizona
city: Tucson
country: United States
facility: Watching Over Mothers & Babies
state: Arizona
city: College Park
country: United States
facility: Paramount Research Solutions
state: Georgia
city: Owensboro
country: United States
facility: Springs Medical Research
state: Kentucky
city: Metairie
country: United States
facility: MedPharmics, LLC
state: Louisiana
city: Gulfport
country: United States
facility: MedPharmics, LLC
state: Mississippi
city: Omaha
country: United States
facility: Quality Clinical Research Inc
state: Nebraska
city: Albuquerque
country: United States
facility: MedPharmics, LLC
state: New Mexico
city: Statesville
country: United States
facility: PMG Research of Peidmont Healthcare
state: North Carolina
city: Fairfield
country: United States
facility: Pediatric Associates of Fairfield, Inc.
state: Ohio
city: Mentor
country: United States
facility: Institute of Clinical Research, LLC
state: Ohio
city: Middleburg Heights
country: United States
facility: The Cleveland Pediatric Research Center, LLC
state: Ohio
city: Sioux Falls
country: United States
facility: Children's Hospital
state: South Dakota
city: Memphis
country: United States
facility: Midsouth Center for Clinical Research
state: Tennessee
city: Fort Worth
country: United States
facility: Ventavia Research Group, Llc
state: Texas
city: Houston
country: United States
facility: Ventavia Research Group
state: Texas
city: Plano
country: United States
facility: Ventavia Research Group, LLC
state: Texas
Study officials:
affiliation: Abbott Nutrition
name: Carlett Ramirez
role: STUDY_CHAIR
References: