Clinical trial NCT04105686: Growth and Tolerance of Young Infants Fed Infant Formula
Official title: Growth and Tolerance of Young Infants Fed Milk-Based Infant Formula With Oligosaccharides
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Growth and Tolerance
Lead sponsor: Abbott Nutrition
Sponsor class: INDUSTRY
First posted: 2019-09-26
Enrollment: 366
Sex: ALL
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, multicenter, controlled, double-blind, parallel study to evaluate growth and tolerance of healthy term infants fed milk-based infant formulas.


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.).
* Parent(s) who elect to formula-feed the participant, confirm their intention to feed their infant the study product as the sole source of feeding during the study.
* Parent(s) who elect to feed the participant human milk, confirm their intention to exclusively feed human milk as the sole source of feeding during the study.
* Parent(s) of formula-fed infants confirm their intention not to administer vitamin or mineral supplements, (except for vitamin D supplements), solid foods or juices to their infant from enrollment through the duration of the study.
* Parent(s) of human milk-fed infants confirm their intention not to administer solid foods or juices to their infant from enrollment through the duration of the study (vitamins and minerals are acceptable).
* Participant's parent(s) has voluntarily signed and dated an ICF, approved by an IRB/IEC and provided HIPAA (or 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 taking medications (including over the counter), prebiotics, probiotics, home remedies, herbal preparations or rehydration fluids that might affect GI tolerance.
* Participant participates in another study that has not been approved as a concomitant study.

Primary outcomes:
measure: Weight
timeFrame: Day of life 14 to Day of life 119
Secondary outcomes:
measure: Stool Characteristics
timeFrame: Study Day 1 to Day of life 119
measure: Formula Tolerance
timeFrame: Study Day 1 to Day of life 119
measure: Length
timeFrame: Day of life 14 to Day of life 119
measure: Head Circumference (HC)
timeFrame: Day of life 14 to Day of life 119
Other outcomes:
measure: Infant and Household Characteristics
timeFrame: Study Day 1 to Day of Life 119
measure: Infant Feeding and Stool Patterns Questionnaire
timeFrame: Exit or Day of life 119
measure: Infant Behavior Questionnaire
timeFrame: Exit or Day of life 42 to Day of life 119
measure: Formula Satisfaction Questionnaire
timeFrame: Exit or Day of life 119
Locations:
city: Birmingham
country: United States
facility: Central Research Associates
state: Alabama
city: Dothan
country: United States
facility: Southeastern Pediatric Associates
state: Alabama
city: Tucson
country: United States
facility: Visions Clinical Research
state: Arizona
city: Little Rock
country: United States
facility: Applied Research Center of Arkansas
state: Arkansas
city: Apopka
country: United States
facility: TOPAZ Clinical Research, Inc.
state: Florida
city: DeLand
country: United States
facility: University Clinical Research-Deland, LLC dba Avail Clinical Research- West Volusia Pediatrics
state: Florida
city: Lake Mary
country: United States
facility: Children's Research, LLC
state: Florida
city: Miami
country: United States
facility: New Horizon Research Center
state: Florida
city: Orlando
country: United States
facility: Pediatric & Adult Research Center
state: Florida
city: Saint Petersburg
country: United States
facility: Score Physician Alliance, LLC
state: Florida
city: Spring Hill
country: United States
facility: Asclepes Research Centers
state: Florida
city: Tampa
country: United States
facility: PAS Research, LLC
state: Florida
city: Chamblee
country: United States
facility: Tekton Research
state: Georgia
city: Nampa
country: United States
facility: Saltzer Health
state: Idaho
city: Evansville
country: United States
facility: Deaconess Clinic, Inc.
state: Indiana
city: Owensboro
country: United States
facility: Springs Medical Research
state: Kentucky
city: Baton Rouge
country: United States
facility: Meridian Clinical Research 3080
state: Louisiana
city: Omaha
country: United States
facility: Meridan Clinical Research
state: Nebraska
city: Las Vegas
country: United States
facility: Wake Research - Clinical Research Center of Nevada
state: Nevada
city: Columbus
country: United States
facility: ClinOhio Research Services
state: Ohio
city: Dayton
country: United States
facility: Ohio Pediatric Research Association
state: Ohio
city: Dayton
country: United States
facility: PriMed Clinical Research
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: Memphis
country: United States
facility: Midsouth Center for Clinical Research
state: Tennessee
city: Memphis
country: United States
facility: Medical Research Center of Memphis
state: Tennessee
city: Beaumont
country: United States
facility: Gadolin Research, LLC
state: Texas
city: Edinburg
country: United States
facility: Women's Hospital at Renaissance - Doctors Hospital at Renaissance
state: Texas
city: Houston
country: United States
facility: Mercury Clincial Research, Inc.
state: Texas
city: Longview
country: United States
facility: DCOL Center for Clinical Research
state: Texas
city: Orem
country: United States
facility: Aspen Clinical Research LLC
state: Utah
city: Tacoma
country: United States
facility: MultiCare Institute for Research and Innovation
state: Washington
Study officials:
affiliation: Abbott Nutrition
name: Timberly Williams, PhD
role: STUDY_CHAIR
References: