Growth and Tolerance of Infants Fed Infant Formulas

This study is currently recruiting participants.
Verified May 2013 by Abbott Nutrition
Sponsor:
Information provided by (Responsible Party):
Abbott Nutrition
ClinicalTrials.gov Identifier:
NCT01808105
First received: March 7, 2013
Last updated: May 23, 2013
Last verified: May 2013
  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


Estimated Enrollment: 368
Study Start Date: April 2013
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2015 (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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01808105

Contacts
Contact: Kristen DeLuca, MS, RD, LD 614-624-5455 kristen.deluca@abbott.com
Contact: Bobbie Swearengin, RN 614-624-7182 bobbie.swearengin@abbott.com

  Show 26 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 23, 2013
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on April 16, 2014