NCT04389606|CompletedDMC
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Sponsor study identifier
interventional
311
1 country
27
Study Start
May 12, 2020
Actual (reported)Primary Completion
June 11, 2021
Actual (reported)Study Completion
June 11, 2021
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 11, 2021
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 12, 2020
Actual (reported)May 12, 2020
Actual (reported)May 15, 2020
Actual (reported)June 11, 2021
Actual (reported)June 11, 2021
Actual (reported)Weight Gain Velocity
G/D
up to 24 weeks
Weight Measures
20 weeks, 24 weeks
Length Measures
20 weeks, 24 weeks
Length Gain Velocity
20 weeks, 24 weeks
Head Circumference Measures
20 weeks, 24 weeks
Weight for age Z-scores
20 weeks, 24 weeks
New infant formula for term infants
Commercially available infant formula for term infants
New infant formula for term infants fed ad lib
Commercially available infant formula for term infants fed ad lib
Alabama Clinical Therapeutics
Birmingham, Alabama, 35126, United States
Watching Over Mothers and Babies
Tucson, Arizona, 85712, United States
The Children's Clinic of Jonesboro, P.A.
Jonesboro, Arkansas, 72401, United States
Applied Research Center of Arkansas
Little Rock, Arkansas, 72212, United States
San Gabriel Women's Health
Arcadia, California, 91007, United States
Northern California Research
Sacramento, California, 95812, United States
Optum
Colorado Springs, Colorado, 80922, United States
Orenstein D, Kuehn D, Knezevic A, Carney M, Camara S, Peltier C. Infant Formula With Added Alpha-Lactalbumin Improves Nighttime Feeding Patterns With Implications for Sleep Quality. J Am Nutr Assoc. 2026 May 7:1-7. doi: 10.1080/27697061.2026.2659830. Online ahead of print.
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.
Devon Kuehn, MD
ByHeart, Inc.
311 participants (actual enrollment reported by the registry).
First Submitted
May 12, 2020
First Posted
May 15, 2020
Study Start
May 12, 2020
Actual (reported)The Effect of Infant Feeding on Stool Characteristics
Human milk
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Topaz Clinical Research
Apopka, Florida, 32703, United States
Sarkis Clinical Trials
Gainesville, Florida, 32607, United States
Avanza Medical Research
Pensacola, Florida, 32503, United States
PAS-Research
Tampa, Florida, 33613, United States
Clinical Research Prime
Idaho Falls, Idaho, 83404, United States
Southern Clinical Research
Zachary, Louisiana, 70791, United States
Sierra Clinical Research
Las Vegas, Nevada, 89106, United States
Pediatric Associates of Mt. Carmel, Inc
Cincinnati, Ohio, 45245, United States
Schear Family Practice
Dayton, Ohio, 45406, United States
Pediatric Associates of Fairfield, Inc.
Fairfield, Ohio, 45014, United States
Institute of Clinical Research
Mentor, Ohio, 44060, United States
Coastal Pediatric Research
Charleston, South Carolina, 29414, United States
Coastal Pediatric Associates
Summerville, South Carolina, 29486, United States
HMG Primary Care at Sapling Grove
Bristol, Tennessee, 37620, United States
Jackson Clinic North
Jackson, Tennessee, 38305, United States
HMG Pediatrics at Kingsport
Kingsport, Tennessee, 37660, United States
Houston Clinical Research Associates
Houston, Texas, 77090, United States
DCOL Center for Clinical Research
Longview, Texas, 75165, United States
ACRC Trials Plano Pediatrics
Plano, Texas, 75093, United States
Tanner Clinic
Layton, Utah, 84041, United States
Primary Completion
June 11, 2021
Actual (reported)Study Completion
June 11, 2021
Actual (reported)Last Updated
July 21, 2021
Record last verified: 2021-07
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Source: ClinicalTrials.gov.
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