Clinical trial NCT03276884: Growth and Tolerance of Young Infants
Official title: Growth and Tolerance of Young Infants Fed Amino Acid-Based Formulas
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Growth
Lead sponsor: Abbott Nutrition
Sponsor class: INDUSTRY
First posted: 2017-09-08
Enrollment: 267
Sex: ALL
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: To compare growth and tolerance of healthy term infants fed two amino acid-based infant formulas.


Eligibility criteria: Inclusion Criteria:

* Subject is judged to be in good health.
* Singleton from a full-term birth with a gestational age of 37 - 42 weeks.
* Birth weight was ≥ 2490 g (\~5 lbs. 8 oz.).
* Subject is between 0 and 8 days of age at enrollment.
* 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 vitamin or mineral supplements (with the exception of Vitamin D-containing supplements), solid foods or juices to their infant from enrollment through the duration of the study.
* Subject's parent(s) has voluntarily signed and dated an ICF prior to any participation in the study.

Exclusion Criteria:

* An adverse maternal, fetal or subject medical history that is thought by the investigator to have potential for effects on tolerance, growth, and/or development.
* Subject is taking and plans to continue medications, home remedies, herbal preparations, prebiotics, probiotics or rehydration fluids that might affect gastrointestinal (GI) tolerance.
* Subject participates in another study that has not been approved as a concomitant study.

Primary outcomes:
measure: Weight Gain
timeFrame: Study Day 14 to Study Day 119
Secondary outcomes:
measure: GI tolerance
timeFrame: Study Day 1 to Study Day 119
measure: Length
timeFrame: Study Day 1 to Study Day 119
measure: Head Circumference
timeFrame: Study Day 1 to Study Day 119
measure: Weight
timeFrame: Study Day 1 to Study Day 119
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Alabama Clinical Therapeutics, LLC
state: Alabama
city: Dothan
country: United States
facility: Southeastern Pediatric Associates
state: Alabama
city: Tucson
country: United States
facility: Watching Over Mothers and Babies
state: Arizona
city: Jonesboro
country: United States
facility: The Children's Clinic of Jonesboro, P.A.
state: Arkansas
city: Norwich
country: United States
facility: Norwich Pediatric Group, PC
state: Connecticut
city: Lake Mary
country: United States
facility: Children's Research, LLC
state: Florida
city: Saint Petersburg
country: United States
facility: Score Physician Alliance, LLC
state: Florida
city: Nampa
country: United States
facility: Saltzer Medical Group
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: Lincoln
country: United States
facility: Women's Clinic of Lincoln, PC
state: Nebraska
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: Charleston
country: United States
facility: Medical Research South
state: South Carolina
city: Charleston
country: United States
facility: Coastal Pediatric Research 3002
state: South Carolina
city: Mount Pleasant
country: United States
facility: Coastal Pediatric Associates 3004
state: South Carolina
city: North Charleston
country: United States
facility: Coastal Pediatric Research 3003
state: South Carolina
city: Memphis
country: United States
facility: Memphis & Shelby County Pediatric Group
state: Tennessee
city: Houston
country: United States
facility: Vilo Research Group Inc
state: Texas
city: San Antonio
country: United States
facility: Southwest Children's Research Associates, PA
state: Texas
city: Layton
country: United States
facility: Tanner Clinic
state: Utah
Study officials:
affiliation: Abbott Nutrition
name: Jan Kajzer, MS, RD, LD
role: STUDY_CHAIR
References: