Growth and Tolerance of Infants Fed Infant Formulas

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01808105
Recruitment Status : Completed
First Posted : March 11, 2013
Last Update Posted : June 2, 2014
Information provided by (Responsible Party):
Abbott Nutrition

Brief Summary:
To evaluate growth and tolerance of healthy term infants fed experimental infant formulas, a commercial infant formula and human breast milk.

Condition or disease Intervention/treatment Phase
Growth and Tolerance Other: Control Formula Other: Experimental Formula 1 Other: Experimental Formula 2 Other: Human Milk Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 424 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Official Title: Growth and Tolerance of Young Infants Fed Infant Formulas
Study Start Date : April 2013
Actual Primary Completion Date : February 2014
Actual Study Completion Date : February 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Human Milk
Reference group, breast feeding ad libitum
Other: Human Milk
Feeding ad libitum
Other Name: Breast feeding group

Active Comparator: Control Formula
Ready to feed infant formula, feed ad libitum
Other: Control Formula
Feeding ad libitum
Other Name: Commercially available Infant Formula

Experimental: Experimental Formula 1
Ready to feed infant formula with human milk oligosaccharides, feed ad libitum
Other: Experimental Formula 1
Feeding ad libitum

Experimental: Experimental Formula 2
Ready to feed infant formula with human milk oligosaccharides, feed ad libitum
Other: Experimental Formula 2
Feeding ad libitum

Primary Outcome Measures :
  1. Weight [ Time Frame: Study Day (SD) 14 - 119 ]
    Weight gain per day

Secondary Outcome Measures :
  1. Stool Characteristics [ Time Frame: Study Day (SD) 1-28; 3 Day Records prior to SD 42, 84 and 119 visits ]
    Stool consistency and number per day

  2. Feeding Tolerance [ Time Frame: Study Day (SD) 1-28; 3 Day Records prior to SD 42, 84 and 119 visits ]
    % of feedings with spit up associated with feeding

  3. Length [ Time Frame: Study Day (SD) 1, 14, 28, 42, 84 and 119 visits ]
    Length and interval length gain per day

  4. Head Circumference [ Time Frame: Study Day (SD) 1, 14, 28, 42, 84 and 119 visits ]
    Head circumference (HC) and interval HC gain per day

Other Outcome Measures:
  1. Study Formula Intake [ Time Frame: Study Day (SD) 1-28; 3 Day Records prior to SD 42, 84 and 119 visits ]
    Average volume of study formula intake and average number of study formula feedings per day

  2. Oligosaccharides [ Time Frame: Study Day (SD) 42 and 119 visits ]
    Infant urine sample

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 5 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01808105

  Hide Study Locations
United States, Alabama
Alabama Clinical Therapeutics, LLC
Birmingham, Alabama, United States, 35205
Alabama Clinical Therapeutics
Dothan, Alabama, United States, 36305
United States, Arizona
W.O.M.B Watching Over Mothers and Babies
Tucson, Arizona, United States, 85712
United States, Colorado
Clinical Research Advantage/Colorado Springs Health Partners
Colorado Springs, Colorado, United States, 80920
United States, Connecticut
Norwich Pediatric Group, PC
Norwich, Connecticut, United States, 06360
United States, Florida
Atlantic Clinical Research Collaborative
Boynton Beach, Florida, United States, 33472
Lake Mary Pediatrics
Orange City, Florida, United States, 32763
SCORE Physician Alliance, LLC
St. Petersburg, Florida, United States, 33710
USF, College of Medicine, Dept of Pediatrics
Tampa, Florida, United States, 33606
United States, Georgia
Southeast Regional Research Group (SERRG)
Columbus, Georgia, United States, 31904
United States, Indiana
PediaResearch, LLC
Evansville, Indiana, United States, 47720
Northpoint Pediatrics, LLC
Indianapolis, Indiana, United States, 46256
Lafayette Clinical Research
Lafayette, Indiana, United States, 47905
United States, Nebraska
Women's Clinic of Lincoln, PC
Lincoln, Nebraska, United States, 68510
United States, Ohio
MetroHealth Medical Center
Cleveland, Ohio, United States, 44109
Dayton Clinical Research
Dayton, Ohio, United States, 45406
Ohio Pediatric Research Association, Inc
Dayton, Ohio, United States, 45414
Institute of Clinical Research
Mayfield Heights, Ohio, United States, 44124
United States, Oregon
Clinical Trials of America
Eugene, Oregon, United States, 97401
United States, Pennsylvania
Red Lion Pediatrics
Philadelphia, Pennsylvania, United States, 19114
United States, South Dakota
Sanford Research
Sioux Falls, South Dakota, United States, 65104
United States, Utah
Tanner Memorial Clinic
Layton, Utah, United States, 84041
United States, Washington
Rockwood Clinic, PS
Spokane, Washington, United States, 99202
Puerto Rico
Clinical Research Puerto Rico
Guayama, Puerto Rico, 00784
Ponce School of Medicine/ CAIMED Center
Ponce, Puerto Rico, 00716
Sponsors and Collaborators
Abbott Nutrition
Study Chair: Jennifer Williams, MPH Abbott Nutrition

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Abbott Nutrition Identifier: NCT01808105     History of Changes
Other Study ID Numbers: AL06
First Posted: March 11, 2013    Key Record Dates
Last Update Posted: June 2, 2014
Last Verified: May 2014