Clinical trial NCT04495738: Infant Formula and Toddler Drink Feeding Intervention
Official title: Infant Formula and Toddler Drink Feeding Intervention Through 24 Months of Age
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Respiratory Infections in Children
Lead sponsor: Abbott Nutrition
Sponsor class: INDUSTRY
First posted: 2020-08-03
Enrollment: 168
Sex: ALL
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 randomized, multi-center, controlled, double-blind, parallel study is to evaluate the health and developmental outcomes of children 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
* Participant's birth weight was ≥ 2490 g (\~5 lbs. 8 oz.)
* If parent(s) elect to formula feed the participant they confirm their intention to feed their participant the study product as the sole source of feeding until 4 months of age, and as the sole milk beverage during the first 12 months of life
* If parent(s) elect to formula feed the participant, they confirm their intention to feed the participant the assigned toddler drink from 12 months of life to 24 months of life as the primary milk beverage
* If parent(s) elect to feed the participant mother's human milk, they confirm that their infant was exclusively fed mother's human milk since birth and confirm their intention to continue exclusively feeding human milk as the sole source of feeding through 4 months of age
* If parent(s) of human milk fed participant elect to supplement or wean after 4 months to 24 months of age, they confirm their intention to use the supplemental/weaning formula or toddler drink as the primary milk beverage
* Parent(s) of formula-fed participant confirm their intention not to administer vitamin or mineral supplements, from enrollment through the duration of the study
* Parent(s) confirm their intention not to administer solid foods or juices to the participant from enrollment through 6 months of age
* 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.

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 medications (including over the counter (OTC), home remedies, 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
* Participant has been treated with antibiotics prior to enrollment

Primary outcomes:
measure: Incidence of respiratory infection between study groups
timeFrame: Study Day 1 to 6 Months of Age
Secondary outcomes:
measure: Infection morbidity between study groups
timeFrame: Study Day 1 to 24 Months of Age
Other outcomes:
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 (HC)
timeFrame: Study Day 1 to 24 Months of Age
measure: Gastrointestinal Tolerance
timeFrame: Study Day 1 to 119 Days of Age
measure: Dietary Intake
timeFrame: Study Day 1 to 24 Months of Age
measure: Infant Feeding and Stool Patterns Questionnaire
timeFrame: 28 Days of Age to 119 Days of Age
measure: Infant Behavior Questionnaire
timeFrame: 119 Days of Age
measure: Formula Satisfaction Questionnaire
timeFrame: 28 Days of Age to 6 Months of Age
measure: Toddler Drink Satisfaction Questionnaire
timeFrame: 15 Months of Age to 24 Months of Age
measure: Human Milk Sample
timeFrame: 84 Days of Age
measure: Stool Sample
timeFrame: Study Day 1 to 24 Months of Age
measure: Saliva Sample
timeFrame: 84 Days of Age
measure: Modified Home Short Form
timeFrame: 6 Months of Age to 24 Months of Age
measure: Behavioral Questionnaire
timeFrame: 12 Months of Age to 24 Months of Age
measure: Ages & Stages Questionnaire
timeFrame: 6 Months of Age to 18 Months of Age
measure: Bayley Scale of Infant & Toddler Development
timeFrame: 12 Months of Age to 24 Months of Age
measure: MacArthur Communicative Developmental Inventory
timeFrame: 12 Months of Age to 24 Months of Age
measure: Edinburgh Postnatal Depression Scale
timeFrame: 28 Days 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
Locations:
city: Dothan
country: United States
facility: Southeastern Pediatric Associates
state: Alabama
city: Tucson
country: United States
facility: Eclipse Clinical Research
state: Arizona
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: Grand Junction
country: United States
facility: Boeson Research 3266
state: Colorado
city: Apopka
country: United States
facility: TOPAZ Clinical Research, Inc.
state: Florida
city: Spring Hill
country: United States
facility: ASCLEPES Research Centers
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 3272
state: Indiana
city: Evansville
country: United States
facility: Deaconess Clinic, Inc.
state: Indiana
city: Owensboro
country: United States
facility: Qualmedica Research, LLC 3270
state: Kentucky
city: Baton Rouge
country: United States
facility: Meridian Clinical Research 3080
state: Louisiana
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: Dayton
country: United States
facility: Ohio Pediatric Research Association
state: Ohio
city: Gresham
country: United States
facility: Cyn3rgy Research
state: Oregon
city: Kingsport
country: United States
facility: Holston Medical Group
state: Tennessee
city: Dickinson
country: United States
facility: MultiCare Institute for Research & Innovation
state: Texas
city: League City
country: United States
facility: Maximos Ob/Gyn
state: Texas
city: Longview
country: United States
facility: DCOL Center for Clinical Research
state: Texas
city: McAllen
country: United States
facility: PAS Research 3273
state: Texas
city: Spokane
country: United States
facility: Multicare Rockwood Pediatrics
state: Washington
city: Tacoma
country: United States
facility: Mercury Clinical Research 3261
state: Washington
Study officials:
affiliation: Abbott Nutrition
name: Bridget Barrett Reis, PhD, RD
role: STUDY_CHAIR
References: