Clinical trial NCT04957992: Infant Formula and Toddler Drink Feeding Study
Official title: Infant Formula and Toddler Drink Feeding Intervention Through 24 Months of Age
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Growth
Lead sponsor: Abbott Nutrition
Sponsor class: INDUSTRY
First posted: 2021-07-12
Enrollment: 607
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: The purpose of this study is to evaluate the growth and development outcomes of infants fed a new infant formula and toddler drink through 24 months of age.


Eligibility criteria: Inclusion Criteria:

* Participant is judged to be in good health as determined from participant's medical history
* Participant is a singleton from a full-term birth with a gestational age of 37 - 42 weeks by parent report
* 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 feeding from Study Visit 1 to 6 months of age, and as the sole milk beverage during the first 12 months of life
* Parent(s) confirm their intention to feed the infant the assigned toddler drink from 12 months of life to 24 months of life as the primary milk beverage
* Parent(s) confirm their intention not to administer vitamin or mineral supplements,(except for vitamin D supplements if instructed by their healthcare professional) from enrollment through the duration of the study
* Parent(s) confirm their intention not to administer solid foods or juices to the infant from enrollment through 6 months of age unless recommended by the participant's HCP
* Participant's parent(s) has voluntarily signed and dated an informed consent form (ICF), approved by an Institutional Review Board/Independent Ethics Committee (IRB/IEC) and provided Health Insurance Portability and Accountability Act (HIPAA) (or other applicable privacy regulation) authorization prior to any participation in the study
* If parent(s) elect to feed the participant human milk, they confirm that their infant was fed human milk since birth and confirm their intention to exclusively feed human milk as the sole source of feeding through 6 months of age.
* If parent(s) of human milk fed participant elect to supplement or wean, they confirm their intention to use the experimental supplemental/weaning formula and experimental toddler drink as the primary milk beverage.

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
* Awareness of a positive drug screen (including but not limited to cocaine, heroin, or methamphetamine) in the mother or participant
* Suspected maternal substance abuse including alcohol
* Participant is taking and plans to continue medications (including over the counter (OTC), such as Mylicon® for gas), home remedies (such as juice for constipation), herbal preparations, prebiotics or probiotics, or rehydration fluids that might affect GI tolerance
* Participant is in another study that has not been approved as a concomitant study by AN
* Participant has been treated with antibiotics (except for topical antibiotics, eye drops) prior to enrollment
* Participant has been treated with other medications (besides antibiotics) that in the opinion of the PI may affect growth, GI tolerance and/or development, prior to enrollment

Primary outcomes:
measure: Growth
timeFrame: Study Day 1 to 6 Months of Age
Secondary outcomes:
measure: Incidence of respiratory infection between study groups
timeFrame: Study Day 1 to 24 Months of Age
measure: Number of respiratory infection episodes between study groups
timeFrame: Study Day 1 to 24 Months of Age
measure: Incidence of infection morbidity between study groups
timeFrame: Study Day 1 to 24 Months of Age
measure: Number of episodes of infection morbidity between study groups
timeFrame: Study Day 1 to 24 Months of Age
measure: Weight
timeFrame: Study Day 1 to 24 Months of Age
measure: Length
timeFrame: Study Day 1 to 24 Months of Age
measure: Head Circumference
timeFrame: Study Day 1 to 24 Months of Age
measure: Gastrointestinal Tolerance
timeFrame: Study Day 1 to 12 months of Age
Other outcomes:
measure: Formula Satisfaction Questionnaire
timeFrame: 28 Days of Age to 6 Months of Age
measure: Toddler Drink Satisfaction Questionnaire
timeFrame: 18 Months of Age to 24 Months of Age
measure: Infant Feeding and Stool Patterns Questionnaire
timeFrame: 28 Days of Age to 119 Days of Age]
measure: Infant and Toddler Behavior Questionnaire
timeFrame: 119 Days of Age
measure: Product Intake
timeFrame: Study Day 1 to 24 Months of Age
measure: Dietary Intake
timeFrame: 6 Months of Age to 24 Months of Age
measure: Stool Sample
timeFrame: Study Day 1 to 24 Months of Age
measure: Bayley™-4 Scale of Infant & Toddler Development IV
timeFrame: 12 Months of Age to 24 Months of Age
measure: MacArthur Communicative Developmental Inventory (CDI)/Words and Gestures and CDI)/Words and Sentences
timeFrame: 12 Months of Age to 24 Months of Age
measure: Modified Home Short Form
timeFrame: 6 Months of Age to 24 Months of Age]
measure: Medications
timeFrame: Study Day 1 to 24 Months of Age
measure: Adverse Events
timeFrame: Study Day 1 to 24 Months of Age
measure: Health Resource Utilization
timeFrame: Study Day 1 to 24 Months of Age
measure: Missed Parental Work Days
timeFrame: Study Day 1 to 24 Months of Age
measure: Blood Collection
timeFrame: 6 and 24 Months of Age
Locations:
city: Phoenix
country: United States
facility: MedPharmics, LLC 3192
state: Arizona
city: Glenwood
country: United States
facility: HealthStar Research
state: Arkansas
city: Hot Springs
country: United States
facility: HealthStar Research, LLC
state: Arkansas
city: Jonesboro
country: United States
facility: The Children's Clinic of Jonesboro, P.A.
state: Arkansas
city: Little Rock
country: United States
facility: Applied Research Center of Arkansas
state: Arkansas
city: Colorado Springs
country: United States
facility: Optumcare Colorado Springs, LLC
state: Colorado
city: Grand Junction
country: United States
facility: Boeson Research 3266
state: Colorado
city: Apopka
country: United States
facility: TOPAZ Clinical Research, Inc.
state: Florida
city: Miami
country: United States
facility: Columbus Clinical Services, LLC.
state: Florida
city: Panama City
country: United States
facility: Emerald Coast OBGYN Clinical Research
state: Florida
city: Spring Hill
country: United States
facility: ASCLEPES Research Centers
state: Florida
city: Tampa
country: United States
facility: Jedidiah Clinical Research
state: Florida
city: Macon
country: United States
facility: Meridian Clinical Research 3259
state: Georgia
city: Idaho Falls
country: United States
facility: Clinical Research Prime
state: Idaho
city: Idaho Falls
country: United States
facility: Leavitt Clinical Research
state: Idaho
city: Evansville
country: United States
facility: Qualmedica Research
state: Indiana
city: Evansville
country: United States
facility: Deaconess Clinic, Inc.
state: Indiana
city: Owensboro
country: United States
facility: Qualmedica Research, LLC
state: Kentucky
city: Baton Rouge
country: United States
facility: Pennington Biomedical Research Center
state: Louisiana
city: Covington
country: United States
facility: MedPharmics, LLC 3343
state: Louisiana
city: Slidell
country: United States
facility: MedPharmics Research 3369
state: Louisiana
city: Great Falls
country: United States
facility: Boeson Research 3367
state: Montana
city: Kalispell
country: United States
facility: Boeson Research 3265
state: Montana
city: Missoula
country: United States
facility: Boeson Research 3267
state: Montana
city: Grand Island
country: United States
facility: Meridian Clinical Research 3264
state: Nebraska
city: Hastings
country: United States
facility: Meridian Clinical Research 3263
state: Nebraska
city: Lincoln
country: United States
facility: Meridian Clinical Research 3304
state: Nebraska
city: Lincoln
country: United States
facility: Alivation Research
state: Nebraska
city: Omaha
country: United States
facility: University of Nebraska Medical Center 3315
state: Nebraska
city: Omaha
country: United States
facility: University of Nebraska Medical Center 3314
state: Nebraska
city: Bronx
country: United States
facility: Advantage Clinical Trials
state: New York
city: Dayton
country: United States
facility: Ohio Pediatric Research Association
state: Ohio
city: Greenville
country: United States
facility: Tribe Clinical Research LLC 3313
state: South Carolina
city: Spartanburg
country: United States
facility: Tribe Clinical Research LLC 3382
state: South Carolina
city: Summerville
country: United States
facility: Coastal Pediatric Research
state: South Carolina
city: Bristol
country: United States
facility: Holston Medical Group 3301
state: Tennessee
city: Kingsport
country: United States
facility: Holston Medical Group 3046
state: Tennessee
city: Memphis
country: United States
facility: AVIATI Healthcare & Clinical Research
state: Tennessee
city: Dallas
country: United States
facility: Javara Inc. 3377
state: Texas
city: League City
country: United States
facility: Maximos Ob/Gyn
state: Texas
city: Pearland
country: United States
facility: AIH Research
state: Texas
city: Richmond
country: United States
facility: National Clinical Research, Inc
state: Virginia
city: Spokane
country: United States
facility: Multicare Health System - Rockwood Pediatrics
state: Washington
Study officials:
affiliation: Abbott Nutrition
name: Elizabeth Reverri, PhD, MS,
role: STUDY_CHAIR
References: