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Growth and Tolerance of Infants Fed Infant Formulas

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01808105
First Posted: March 11, 2013
Last Update Posted: June 2, 2014
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.
Information provided by (Responsible Party):
Abbott Nutrition
  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: Triple (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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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
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 ClinicalTrials.gov identifier (NCT number): NCT01808105


  Show 25 Study Locations
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
First Submitted: March 7, 2013
First Posted: March 11, 2013
Last Update Posted: June 2, 2014
Last Verified: May 2014