Clinical trial NCT04218929: Evaluation of Growth, Safety, and Efficacy of an Infant Formula for Healthy Term Infants
Official title: Evaluation of Growth, Safety, and Efficacy of an Infant Formula for Healthy Term Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infants
Newborn
Keywords: Infant
Infant Formula
Healthy Subjects
Lead sponsor: ByHeart
Sponsor class: INDUSTRY
Collaborators: name: Paidion Research, Inc.
First posted: 2020-01-06
Enrollment: 311
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 demonstrate that a new infant formula for term infants supports age-appropriate growth. This study is designed in accordance with Good Clinical Practice guidelines and the requirements of the Code of Federal Regulations, 21CFR106.96. In this randomized, controlled trial (RCT), healthy, term, formula-fed (FF) infants will be randomized to one of two infant formulas: a standard, commercially-available infant formula for term infants (CF) or the study formula for term infants (SF) for 16 weeks. A reference group of human milk-fed infants will also be enrolled. The primary efficacy objective is to compare the growth of infants randomized to the study infant formula (SF) versus growth of infants randomized to the standard commercial infant formula (CF).


Eligibility criteria: Inclusion Criteria:

* Term (no less than 37 weeks, 0 days and less than 42 weeks, 0 days), singleton infant.
* Birth weight of greater than or equal to 2500 grams.
* Designated healthy by a physician.
* Less than or equal to 14 days of age at enrollment.
* If formula fed, exclusively consuming and tolerating a cow's milk infant formula at enrollment and have a parent who agrees to feed the study formula as a sole source of nutrition for a minimum of 16 weeks.
* If human milk fed, predominantly consuming and tolerating human milk and have a mother/parent who plans to predominantly feed human milk as sole source of nutrition for a minimum of 16 weeks.
* Weight for age greater than or equal to 5th percentile and less than or equal to 95th percentile at enrollment.
* Length for age greater than or equal to 5th percentile and less than or equal to 95th percentile at enrollment.
* Head circumference for age greater than or equal to 5th percentile and less than or equal to 95th percentile at enrollment.
* Weight for length greater than or equal to 5th percentile and less than or equal to 95th percentile at enrollment.
* Not currently receiving and have a parent/guardian who does not plan to give pre- and/or pro-biotics for the full duration of the study.
* Not currently participating in an interventional clinical trial and have a parent(s) or legal guardian(s) who agree not to enroll the infant in an interventional clinical trial while participating in this trial.
* Have parent(s) or legal guardian(s) who are capable of completing the written records, questionnaires, and study procedures required by the protocol.
* Have a parent(s) or legal guardian(s) who have read and voluntarily signed the Institutional Review Board Informed Consent prior to study participation.

Exclusion Criteria:

* Evidence of any anatomic or physiologic condition that would interfere with normal growth, development, or feeding.
* Infants required to take medications know to influence growth and development.
* Maternal history with known adverse effects on the fetus and/or the newborn infants.
* Family history of cow milk protein allergy or soy intolerance/allergy.
* Infants receiving any amount supplemental human milk with infant formula or visa-versa at time of enrollment.
* Infants from a multiple birth.

Primary outcomes:
measure: Weight Gain Velocity
timeFrame: 0 - 16 weeks
Secondary outcomes:
measure: Weight Measures
timeFrame: 0 - 16 weeks
measure: Length Measures
timeFrame: 0 - 16 weeks
measure: Length Gain Velocity
timeFrame: 0 - 16 weeks
measure: Head Circumference Measures
timeFrame: 0 - 16 weeks
measure: Weight for age Z-scores
timeFrame: 0 - 16 weeks
measure: Length for age Z-scores
timeFrame: 0 - 16 weeks
measure: Head circumference for age Z-scores
timeFrame: 0 - 16 weeks
measure: Weight for length Z-scores
timeFrame: 0 - 16 weeks
measure: 72-hr record of formula intake at each study visit
timeFrame: 0 - 16 weeks
measure: Blood concentrations of Interleukin-6 (pg/mL), Interleukin-10 (pg/mL), and tumor necrosis factor-alpha (pg/mL)
timeFrame: 16 weeks
measure: Blood concentrations of amino acids (umol/L)
timeFrame: 16 weeks
measure: Human milk composition (concentrations of proteins, lipids, carbohydrates, vitamins, and minerals
timeFrame: 3 weeks, 7 weeks
measure: Medically-diagnosed adverse events collected throughout the study period
timeFrame: 0 through 16 weeks
measure: Parent rating of infant stool consistency at each study visit
timeFrame: 0 - 16 weeks
measure: Parent report of infant stool frequency at each study visit
timeFrame: 0 - 16 weeks
measure: Parent report of infant disposition (fussiness, crying, gas, spit up, Infant Characteristics Questionnaire) at each study visit
timeFrame: 0 - 16 weeks
measure: Stool microbiome
timeFrame: 2 weeks, 16 weeks
measure: Stool metabolome
timeFrame: 2 weeks, 16 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.