Clinical trial NCT04389606: Follow-up Study of Growth, Safety, and Efficacy of an Infant Formula for Healthy Term Infants
Official title: Follow-up Study of Growth, Safety, and Efficacy of an Infant Formula for Healthy Term Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Term Infants
Keywords: Infant
Infant Formula
Healthy Subjects
Lead sponsor: ByHeart
Sponsor class: INDUSTRY
Collaborators: name: Paidion Research, Inc.
First posted: 2020-05-15
Enrollment: 311
Sex: ALL
Minimum age (years): 16
Maximum age (years): 19
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this two-month follow-up study is to continue to follow growth, safety, and other health outcomes of infants fed a new infant formula for term infants or comparator formula. A reference group of human milk-fed infants will also be followed. This study is designed in accordance with Good Clinical Practice guidelines.


Eligibility criteria: Inclusion Criteria:

* Subjects who enrolled and completed the previous phase of the clinical trial: NCT04218929 "Evaluation of Growth, Safety, and Efficacy of an Infant Formula for Healthy Term Infants"

Exclusion Criteria:

* Subjects who did not enroll in the previous phase of the clinical trial: NCT04218929 "Evaluation of Growth, Safety, and Efficacy of an Infant Formula for Healthy Term Infants"

Primary outcomes:
measure: Weight Gain Velocity
timeFrame: up to 24 weeks
Secondary outcomes:
measure: Weight Measures
timeFrame: 20 weeks, 24 weeks
measure: Length Measures
timeFrame: 20 weeks, 24 weeks
measure: Length Gain Velocity
timeFrame: 20 weeks, 24 weeks
measure: Head Circumference Measures
timeFrame: 20 weeks, 24 weeks
measure: Weight for age Z-scores
timeFrame: 20 weeks, 24 weeks
measure: Length for age Z-scores
timeFrame: 20 weeks, 24 weeks
measure: Head circumference for age Z-scores
timeFrame: 20 weeks, 24 weeks
measure: Weight for length Z-scores
timeFrame: 20 weeks, 24 weeks
measure: 72-hr record of formula intake at each study visit
timeFrame: 20 weeks, 24 weeks
measure: Blood concentrations of Interleukin-6 (pg/mL), Interleukin-10 (pg/mL), and tumor necrosis factor-alpha (pg/mL)
timeFrame: 24 weeks
measure: Blood concentrations of amino acids (umol/L)
timeFrame: 24 weeks
measure: Human milk composition (concentrations of proteins, lipids, carbohydrates, vitamins, and minerals
timeFrame: 24 weeks
measure: Medically-diagnosed adverse events collected throughout the study period
timeFrame: 16-24 weeks
measure: Parent rating of infant stool consistency at each study visit
timeFrame: 20 weeks, 24 weeks
measure: Parent report of infant stool frequency at each study visit
timeFrame: 20 weeks, 24 weeks
measure: Parent report of infant disposition (fussiness, crying, gas, spit up, Infant Characteristics Questionnaire) at each study visit
timeFrame: 20 weeks, 24 weeks
measure: Stool microbiome
timeFrame: 24 weeks
measure: Stool metabolome
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Alabama Clinical Therapeutics
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: Little Rock
country: United States
facility: Applied Research Center of Arkansas
state: Arkansas
city: Arcadia
country: United States
facility: San Gabriel Women's Health
state: California
city: Sacramento
country: United States
facility: Northern California Research
state: California
city: Colorado Springs
country: United States
facility: Optum
state: Colorado
city: Apopka
country: United States
facility: Topaz Clinical Research
state: Florida
city: Gainesville
country: United States
facility: Sarkis Clinical Trials
state: Florida
city: Pensacola
country: United States
facility: Avanza Medical Research
state: Florida
city: Tampa
country: United States
facility: PAS-Research
state: Florida
city: Idaho Falls
country: United States
facility: Clinical Research Prime
state: Idaho
city: Zachary
country: United States
facility: Southern Clinical Research
state: Louisiana
city: Las Vegas
country: United States
facility: Sierra Clinical Research
state: Nevada
city: Cincinnati
country: United States
facility: Pediatric Associates of Mt. Carmel, Inc
state: Ohio
city: Dayton
country: United States
facility: Schear Family Practice
state: Ohio
city: Fairfield
country: United States
facility: Pediatric Associates of Fairfield, Inc.
state: Ohio
city: Mentor
country: United States
facility: Institute of Clinical Research
state: Ohio
city: Charleston
country: United States
facility: Coastal Pediatric Research
state: South Carolina
city: Summerville
country: United States
facility: Coastal Pediatric Associates
state: South Carolina
city: Bristol
country: United States
facility: HMG Primary Care at Sapling Grove
state: Tennessee
city: Jackson
country: United States
facility: Jackson Clinic North
state: Tennessee
city: Kingsport
country: United States
facility: HMG Pediatrics at Kingsport
state: Tennessee
city: Houston
country: United States
facility: Houston Clinical Research Associates
state: Texas
city: Longview
country: United States
facility: DCOL Center for Clinical Research
state: Texas
city: Plano
country: United States
facility: ACRC Trials Plano Pediatrics
state: Texas
city: Layton
country: United States
facility: Tanner Clinic
state: Utah
Study officials:
affiliation: ByHeart, Inc.
name: Devon Kuehn, MD
role: STUDY_DIRECTOR
References:
citation: Kuehn D, Zeisel SH, Orenstein DF, German JB, Field CJ, Teerdhala S, Knezevic A, Patil S, Donovan SM, Lonnerdal B. Effects of a Novel High-Quality Protein Infant Formula on Energetic Efficiency and Tolerance: A Randomized Trial. J Pediatr Gastroenterol Nutr. 2022 Oct 1;75(4):521-528. doi: 10.1097/MPG.0000000000003490. Epub 2022 Jun 6.