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Growth and Tolerance of Healthy Term Infants to a New Infant Formula

This study has been terminated.
(The control product was recalled.)
Sponsor:
Information provided by:
Abbott Nutrition
ClinicalTrials.gov Identifier:
NCT01137877
First received: June 3, 2010
Last updated: November 24, 2010
Last verified: November 2010
History of Changes

June 3, 2010
November 24, 2010
May 2010
October 2010   (final data collection date for primary outcome measure)
weight gain [ Time Frame: 14 to 119 days of age ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01137877 on ClinicalTrials.gov Archive Site
  • GI tolerance [ Time Frame: 14 to 119 days of age ] [ Designated as safety issue: No ]
  • anthropometrics [ Time Frame: 14 to 119 days of age ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Growth and Tolerance of Healthy Term Infants to a New Infant Formula
Growth and Tolerance of Healthy Term Infants to a New Infant Formula

The objective of this study is to evaluate the effect of two experimental milk-based infant formulas on the growth and gastrointestinal (GI) tolerance of term infants.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Healthy Term Infants
  • Other: Milk based infant formula powder
    milk based infant formula ad lib
  • Other: Investigational Infant Formula #1
    Milk based infant formula ad lib
  • Other: Investigational Infant Formula #2
    Milk based infant formula powder ad lib
  • Other: Human Milk
    Human milk ad lib
  • Active Comparator: Infant Formula #1
    Milk-based Infant Formula Powder
    Intervention: Other: Milk based infant formula powder
  • Experimental: Investigational Infant Formula #1
    Investigational Milk-based Infant Formula Powder
    Intervention: Other: Investigational Infant Formula #1
  • Experimental: Investigational Infant Formula #2
    Investigational Milk based infant formula powder
    Intervention: Other: Investigational Infant Formula #2
  • Active Comparator: Human Milk
    Reference group
    Intervention: Other: Human Milk
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
399
October 2010
October 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • in good health
  • singleton full term birth
  • Birth weight > 2490 g.
  • Infant is between 0 and 11 days of age
  • Infants using medications , home remedies , herbal preparations, prebiotics, probiotics or rehydration fluids that might affect GI tolerance
  • If formula-fed, parent(s) confirm their intention to feed their infant the study product as the sole source of nutrition for the duration of the study
  • If human milk-fed, parent(s) confirm their intention to feed their infant human milk as the sole source of nutrition
  • not consuming vitamin or mineral supplements, solid foods or juices through the duration of the study

Exclusion Criteria:

adverse maternal, fetal or infant medical history with potential for effects on tolerance, growth, and/or development.
Both
up to 11 Days
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01137877
AK66
Yes
Bobbie Swearengin, Director Clinical Research Operations, Abbott Nutrition
Abbott Nutrition
Not Provided
Study Chair: Timberly Williams, PhD Abbott Nutrition
Abbott Nutrition
November 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP