Evaluation of Growth, Safety, and Efficacy of an Infant Formula for Healthy Term Infants
- Conditions
- InfantsNewborn
- Interventions
- Other: Study Formula (SF)Other: Comparator Formula (CF)
- Registration Number
- NCT04218929
- Lead Sponsor
- ByHeart
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 311
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Study Formula (SF) Study Formula (SF) New infant formula for term infants Comparator Formula (CF) Comparator Formula (CF) Commercially available infant formula for term infants
- Primary Outcome Measures
Name Time Method Weight Gain Velocity 0 - 16 weeks G/D
- Secondary Outcome Measures
Name Time Method Weight for age Z-scores 0 - 16 weeks Weight for age Z-scores compared to World Health Organization (WHO) growth standards
72-hr record of formula intake at each study visit 0 - 16 weeks OZ/D
Human milk composition (concentrations of proteins, lipids, carbohydrates, vitamins, and minerals 3 weeks, 7 weeks Concentration
Medically-diagnosed adverse events collected throughout the study period 0 through 16 weeks Frequency
Parent report of infant stool frequency at each study visit 0 - 16 weeks Mean
Stool metabolome 2 weeks, 16 weeks Targeted and Untargeted Metabolomics
Blood concentrations of Interleukin-6 (pg/mL), Interleukin-10 (pg/mL), and tumor necrosis factor-alpha (pg/mL) 16 weeks Concentration
Length for age Z-scores 0 - 16 weeks Length for age Z-scores compared to WHO growth standards
Blood concentrations of amino acids (umol/L) 16 weeks Concentration
Weight Measures 0 - 16 weeks KG
Head Circumference Measures 0 - 16 weeks CM
Length Measures 0 - 16 weeks CM
Weight for length Z-scores 0 - 16 weeks Weight for length Z-scores compared to WHO growth standards
Length Gain Velocity 0 - 16 weeks CM/D
Head circumference for age Z-scores 0 - 16 weeks Head circumference for age Z-scores compared to WHO growth standards
Parent rating of infant stool consistency at each study visit 0 - 16 weeks Mean. Quinlan et al Likert scale; 0=no bowel movement, 1=hard \[dry hard pellets\], 2=formed \[definite shape, not dry\], 3=soft \[no definite shape, pasty\], 4=loose \[no shape, some water\], 5=watery \[no shape, mainly water\]).
Parent report of infant disposition (fussiness, crying, gas, spit up, Infant Characteristics Questionnaire) at each study visit 0 - 16 weeks Mean
Stool microbiome 2 weeks, 16 weeks Fecal microbial taxa and community abundance
Trial Locations
- Locations (27)
Topaz Clinical Research
🇺🇸Apopka, Florida, United States
Pediatric Associates of Fairfield, Inc.
🇺🇸Fairfield, Ohio, United States
Alabama Clinical Therapeutics
🇺🇸Birmingham, Alabama, United States
Avanza Medical Research
🇺🇸Pensacola, Florida, United States
Sarkis Clinical Trials
🇺🇸Gainesville, Florida, United States
DCOL Center for Clinical Research
🇺🇸Longview, Texas, United States
ACRC Trials Plano Pediatrics
🇺🇸Plano, Texas, United States
Houston Clinical Research Associates
🇺🇸Houston, Texas, United States
Watching Over Mothers and Babies
🇺🇸Tucson, Arizona, United States
San Gabriel Women's Health
🇺🇸Arcadia, California, United States
Optum
🇺🇸Colorado Springs, Colorado, United States
Northern California Research
🇺🇸Sacramento, California, United States
PAS-Research
🇺🇸Tampa, Florida, United States
Pediatric Associates of Mt. Carmel, Inc
🇺🇸Cincinnati, Ohio, United States
The Children's Clinic of Jonesboro, P.A.
🇺🇸Jonesboro, Arkansas, United States
Clinical Research Prime
🇺🇸Idaho Falls, Idaho, United States
Sierra Clinical Research
🇺🇸Las Vegas, Nevada, United States
Jackson Clinic North
🇺🇸Jackson, Tennessee, United States
HMG Primary Care at Sapling Grove
🇺🇸Bristol, Tennessee, United States
Southern Clinical Research
🇺🇸Zachary, Louisiana, United States
Applied Research Center of Arkansas
🇺🇸Little Rock, Arkansas, United States
Coastal Pediatric Research
🇺🇸Charleston, South Carolina, United States
Tanner Clinic
🇺🇸Layton, Utah, United States
HMG Pediatrics at Kingsport
🇺🇸Kingsport, Tennessee, United States
Schear Family Practice
🇺🇸Dayton, Ohio, United States
Institute of Clinical Research
🇺🇸Mentor, Ohio, United States
Coastal Pediatric Associates
🇺🇸Summerville, South Carolina, United States