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Growth and Tolerance of Infants Fed Infant Formulas

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Abbott Nutrition
ClinicalTrials.gov Identifier:
NCT01808105
First received: March 7, 2013
Last updated: May 30, 2014
Last verified: May 2014
  Purpose
To evaluate growth and tolerance of healthy term infants fed experimental infant formulas, a commercial infant formula and human breast milk.

Condition Intervention
Growth and Tolerance Other: Control Formula Other: Experimental Formula 1 Other: Experimental Formula 2 Other: Human Milk

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator)
Official Title: Growth and Tolerance of Young Infants Fed Infant Formulas

Resource links provided by NLM:


Further study details as provided by Abbott Nutrition:

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


Secondary Outcome Measures:
  • 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

  • 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

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

  • 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:
  • 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

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


Enrollment: 424
Study Start Date: April 2013
Study Completion Date: February 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01808105

  Hide Study Locations
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
Investigators
Study Chair: Jennifer Williams, MPH Abbott Nutrition
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Abbott Nutrition
ClinicalTrials.gov Identifier: NCT01808105     History of Changes
Other Study ID Numbers: AL06
Study First Received: March 7, 2013
Last Updated: May 30, 2014

ClinicalTrials.gov processed this record on June 22, 2017