Growth and Tolerance of Infants Fed Infant Formulas
Growth and Tolerance of Young Infants Fed Infant Formulas
1 other identifier
interventional
424
2 countries
25
Brief Summary
To evaluate growth and tolerance of healthy term infants fed experimental infant formulas, a commercial infant formula and human breast milk.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2013
Shorter than P25 for not_applicable
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 7, 2013
CompletedFirst Posted
Study publicly available on registry
March 11, 2013
CompletedStudy Start
First participant enrolled
April 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2014
CompletedJune 2, 2014
May 1, 2014
10 months
March 7, 2013
May 30, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Weight
Weight gain per day
Study Day (SD) 14 - 119
Secondary Outcomes (4)
Stool Characteristics
Study Day (SD) 1-28; 3 Day Records prior to SD 42, 84 and 119 visits
Feeding Tolerance
Study Day (SD) 1-28; 3 Day Records prior to SD 42, 84 and 119 visits
Length
Study Day (SD) 1, 14, 28, 42, 84 and 119 visits
Head Circumference
Study Day (SD) 1, 14, 28, 42, 84 and 119 visits
Other Outcomes (2)
Study Formula Intake
Study Day (SD) 1-28; 3 Day Records prior to SD 42, 84 and 119 visits
Oligosaccharides
Study Day (SD) 42 and 119 visits
Study Arms (4)
Human Milk
OTHERReference group, breast feeding ad libitum
Control Formula
ACTIVE COMPARATORReady to feed infant formula, feed ad libitum
Experimental Formula 1
EXPERIMENTALReady to feed infant formula with human milk oligosaccharides, feed ad libitum
Experimental Formula 2
EXPERIMENTALReady to feed infant formula with human milk oligosaccharides, feed ad libitum
Interventions
Feeding ad libitum
Eligibility Criteria
You may qualify if:
- Singleton from full term birth with a gestational age 37-42 weeks
- Birth weight \> 2490 g (\~5 lbs 8 oz)
- Between 0 and 5 days of age
- Smoke-free home (no smoking in the house dwelling), and mothers in the breast-fed group are prohibited from smoking during the study period
- Parent(s) of formula-fed infants have elected not to breastfeed and confirm that their infant has been exclusively formula-fed since birth and confirm their intention is to exclusively feed their infant study infant formula for the duration of the study,
- Parent(s) of human milk-fed infants have elected to breastfeed and confirm that their infant has been exclusively human milk-fed (not donor milk) since birth and confirm their intention is to continue to exclusively feed human milk with vitamin/mineral supplementation for the duration of the study
- No administration vitamin or mineral supplements (excluding vitamin or mineral supplements containing vitamin D, if recommended by a healthcare professional), solid foods or juices to infants from enrollment through the duration of the study, unless instructed otherwise by their healthcare professional
You may not qualify if:
- Adverse maternal, fetal or infant medical history that has potential effects on tolerance, growth, and/or development
- Infants using medications, home remedies, herbal preparations, probiotics or rehydration fluids that might affect gastrointestinal (GI) tolerance may not be enrolled
- Treatment with antibiotics
- Mother intends to use a combination of breast and formula feeding
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Abbott Nutritionlead
Study Sites (25)
Alabama Clinical Therapeutics, LLC
Birmingham, Alabama, 35205, United States
Alabama Clinical Therapeutics
Dothan, Alabama, 36305, United States
W.O.M.B Watching Over Mothers and Babies
Tucson, Arizona, 85712, United States
Clinical Research Advantage/Colorado Springs Health Partners
Colorado Springs, Colorado, 80920, United States
Norwich Pediatric Group, PC
Norwich, Connecticut, 06360, United States
Atlantic Clinical Research Collaborative
Boynton Beach, Florida, 33472, United States
Lake Mary Pediatrics
Orange City, Florida, 32763, United States
SCORE Physician Alliance, LLC
St. Petersburg, Florida, 33710, United States
USF, College of Medicine, Dept of Pediatrics
Tampa, Florida, 33606, United States
Southeast Regional Research Group (SERRG)
Columbus, Georgia, 31904, United States
PediaResearch, LLC
Evansville, Indiana, 47720, United States
Northpoint Pediatrics, LLC
Indianapolis, Indiana, 46256, United States
Lafayette Clinical Research
Lafayette, Indiana, 47905, United States
Women's Clinic of Lincoln, PC
Lincoln, Nebraska, 68510, United States
MetroHealth Medical Center
Cleveland, Ohio, 44109, United States
Dayton Clinical Research
Dayton, Ohio, 45406, United States
Ohio Pediatric Research Association, Inc
Dayton, Ohio, 45414, United States
Institute of Clinical Research
Mayfield Heights, Ohio, 44124, United States
Clinical Trials of America
Eugene, Oregon, 97401, United States
Red Lion Pediatrics
Philadelphia, Pennsylvania, 19114, United States
Sanford Research
Sioux Falls, South Dakota, 65104, United States
Tanner Memorial Clinic
Layton, Utah, 84041, United States
Rockwood Clinic, PS
Spokane, Washington, 99202, United States
Clinical Research Puerto Rico
Guayama, 00784, Puerto Rico
Ponce School of Medicine/ CAIMED Center
Ponce, 00716, Puerto Rico
Related Publications (2)
Hill DR, Buck RH. Infants Fed Breastmilk or 2'-FL Supplemented Formula Have Similar Systemic Levels of Microbiota-Derived Secondary Bile Acids. Nutrients. 2023 May 17;15(10):2339. doi: 10.3390/nu15102339.
PMID: 37242222DERIVEDGoehring KC, Marriage BJ, Oliver JS, Wilder JA, Barrett EG, Buck RH. Similar to Those Who Are Breastfed, Infants Fed a Formula Containing 2'-Fucosyllactose Have Lower Inflammatory Cytokines in a Randomized Controlled Trial. J Nutr. 2016 Dec;146(12):2559-2566. doi: 10.3945/jn.116.236919. Epub 2016 Oct 26.
PMID: 27798337DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Jennifer Williams, MPH
Abbott Nutrition
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 7, 2013
First Posted
March 11, 2013
Study Start
April 1, 2013
Primary Completion
February 1, 2014
Study Completion
February 1, 2014
Last Updated
June 2, 2014
Record last verified: 2014-05