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 (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    % of feedings with spit up associated with feeding

  • Length [ Time Frame: Study Day (SD) 1, 14, 28, 42, 84 and 119 visits ] [ Designated as safety issue: No ]
    Length and interval length gain per day

  • Head Circumference [ Time Frame: Study Day (SD) 1, 14, 28, 42, 84 and 119 visits ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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
Genders Eligible for Study:   Both
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

  Show 25 Study Locations
Sponsors and Collaborators
Abbott Nutrition
Investigators
Study Chair: Jennifer Williams, MPH Abbott Nutrition
  More Information

No publications provided

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
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on July 29, 2014