Follow-up Study of Growth, Safety, and Efficacy of an Infant Formula for Healthy Term Infants
- Conditions
- Term InfantsHealthy
- Interventions
- Other: Study Formula (SF)Other: Comparator Formula (CF)
- Registration Number
- NCT04389606
- Lead Sponsor
- ByHeart
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 311
- 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"
- 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"
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Comparator Formula (CF) Comparator Formula (CF) Commercially available infant formula for term infants Comparator Formula (CF) Study Formula (SF) Commercially available infant formula for term infants Study Formula (SF) Study Formula (SF) New infant formula for term infants Study Formula (SF) Comparator Formula (CF) New infant formula for term infants
- Primary Outcome Measures
Name Time Method Weight Gain Velocity up to 24 weeks G/D
- Secondary Outcome Measures
Name Time Method Human milk composition (concentrations of proteins, lipids, carbohydrates, vitamins, and minerals 24 weeks Concentration
Weight Measures 20 weeks, 24 weeks KG
Weight for length Z-scores 20 weeks, 24 weeks Weight for length Z-scores compared to WHO growth standards
Parent report of infant stool frequency at each study visit 20 weeks, 24 weeks Mean
Weight for age Z-scores 20 weeks, 24 weeks Weight for age Z-scores compared to World Health Organization (WHO) growth standards
Stool microbiome 24 weeks Fecal microbial taxa and community abundance
Head Circumference Measures 20 weeks, 24 weeks CM
Length for age Z-scores 20 weeks, 24 weeks Length for age Z-scores compared to WHO growth standards
Blood concentrations of amino acids (umol/L) 24 weeks Concentration
Length Measures 20 weeks, 24 weeks CM
Length Gain Velocity 20 weeks, 24 weeks CM/D
Head circumference for age Z-scores 20 weeks, 24 weeks Head circumference for age Z-scores compared to WHO growth standards
72-hr record of formula intake at each study visit 20 weeks, 24 weeks oz/d
Blood concentrations of Interleukin-6 (pg/mL), Interleukin-10 (pg/mL), and tumor necrosis factor-alpha (pg/mL) 24 weeks Concentration
Medically-diagnosed adverse events collected throughout the study period 16-24 weeks Frequency
Parent rating of infant stool consistency at each study visit 20 weeks, 24 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 20 weeks, 24 weeks Mean
Stool metabolome 24 weeks Targeted and Untargeted Metabolomics
Related Research Topics
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Trial Locations
- Locations (27)
Alabama Clinical Therapeutics
🇺🇸Birmingham, Alabama, United States
Watching Over Mothers and Babies
🇺🇸Tucson, Arizona, United States
Applied Research Center of Arkansas
🇺🇸Little Rock, Arkansas, United States
San Gabriel Women's Health
🇺🇸Arcadia, California, United States
Northern California Research
🇺🇸Sacramento, California, United States
Optum
🇺🇸Colorado Springs, Colorado, United States
Topaz Clinical Research
🇺🇸Apopka, Florida, United States
Sarkis Clinical Trials
🇺🇸Gainesville, Florida, United States
PAS-Research
🇺🇸Tampa, Florida, United States
Avanza Medical Research
🇺🇸Pensacola, Florida, United States
Pediatric Associates of Mt. Carmel, Inc
🇺🇸Cincinnati, Ohio, United States
Schear Family Practice
🇺🇸Dayton, Ohio, United States
Pediatric Associates of Fairfield, Inc.
🇺🇸Fairfield, Ohio, United States
Institute of Clinical Research
🇺🇸Mentor, Ohio, United States
Coastal Pediatric Research
🇺🇸Charleston, South Carolina, United States
Coastal Pediatric Associates
🇺🇸Summerville, South Carolina, United States
Houston Clinical Research Associates
🇺🇸Houston, Texas, United States
DCOL Center for Clinical Research
🇺🇸Longview, Texas, United States
Tanner Clinic
🇺🇸Layton, Utah, United States
ACRC Trials Plano Pediatrics
🇺🇸Plano, Texas, United States
HMG Primary Care at Sapling Grove
🇺🇸Bristol, Tennessee, United States
Sierra Clinical Research
🇺🇸Las Vegas, Nevada, United States
Jackson Clinic North
🇺🇸Jackson, Tennessee, United States
The Children's Clinic of Jonesboro, P.A.
🇺🇸Jonesboro, Arkansas, United States
Clinical Research Prime
🇺🇸Idaho Falls, Idaho, United States
Southern Clinical Research
🇺🇸Zachary, Louisiana, United States
HMG Pediatrics at Kingsport
🇺🇸Kingsport, Tennessee, United States