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.

Study Overview

• Status: Terminated
• Conditions: Healthy Term Infants
• Intervention / Treatment: Other: Milk based infant formula powder; Other: Investigational Infant Formula #1; Other: Investigational Infant Formula #2; Other: Human Milk

• Study Type: Interventional
• Enrollment (Actual): 399
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72202
      • Arkansas Children's Hospital Research
  • California
    • Mission Hills, California, United States, 91345
      • Facey Medical Foundation
  • Connecticut
    • Norwich, Connecticut, United States, 06360
      • Norwich Pediatric Group
  • Florida
    • Plantation, Florida, United States, 33324
      • All Women's Healthcare of West Broward, Inc
    • St. Petersburg, Florida, United States, 33710
      • SCORE Physician Alliance LLC
    • Tampa, Florida, United States, 33606
      • USF College of Medicine, USF Health, Department of Pediatrics
  • Indiana
    • Indianapolis, Indiana, United States, 46038
      • Northpoint Pediatrics
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • University of Louisville Department of Pediatrics
  • Massachusetts
    • Fall River, Massachusetts, United States, 02720
      • New England Center for Clinical Research, Inc
  • Minnesota
    • Chaska, Minnesota, United States, 55318
      • Wayzata Children's Clinic Ridgeview Research
  • Nebraska
    • Lincoln, Nebraska, United States, 68504
      • Midwest Children's Health Research Institute, LLC
  • Nevada
    • Las Vegas, Nevada, United States, 89123
      • Clinical Research Center of Nevada
  • North Carolina
    • Cary, North Carolina, United States, 27518
      • Cary Pediatric Center
  • Ohio
    • Dayton, Ohio, United States, 45406
      • Dayton Clinical Research
    • Huber Heights, Ohio, United States, 45424
      • Ohio Pediatric Research Association, Inc
    • Parma, Ohio, United States, 44129
      • Parma Pediatrics
    • Westlake, Ohio, United States, 44145
      • Comprehensive Pediatrics, Inc
  • South Dakota
    • Sioux Falls, South Dakota, United States, 57105
      • Sanford Clinic Family Medicine 34th and Kiwanis
  • Texas
    • Longview, Texas, United States, 75605
      • DCOL Center for Clinical Research
  • Washington
    • Spokane, Washington, United States, 99218
      • Rockwood Clinic North Pediatrics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 1 week (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Infant Formula #1; Milk-based Infant Formula Powder	Other: Milk based infant formula powder; milk based infant formula ad lib
Experimental: Investigational Infant Formula #1; Investigational Milk-based Infant Formula Powder	Other: Investigational Infant Formula #1; Milk based infant formula ad lib
Experimental: Investigational Infant Formula #2; Investigational Milk based infant formula powder	Other: Investigational Infant Formula #2; Milk based infant formula powder ad lib
Active Comparator: Human Milk; Reference group	Other: Human Milk; Human milk ad lib

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
weight gain	14 to 119 days of age

Secondary Outcome Measures

Outcome Measure	Time Frame
GI tolerance	14 to 119 days of age
anthropometrics	14 to 119 days of age

Collaborators and Investigators

• Sponsor: Abbott Nutrition

Study record dates

Study Major Dates

• Study Start: May 1, 2010
• Primary Completion (Actual): October 1, 2010
• Study Completion (Actual): October 1, 2010

Study Registration Dates

• First Submitted: June 3, 2010
• First Submitted That Met QC Criteria: June 3, 2010
• First Posted (Estimate): June 7, 2010

Study Record Updates

• Last Update Posted (Estimate): November 25, 2010
• Last Update Submitted That Met QC Criteria: November 24, 2010
• Last Verified: November 1, 2010

More Information

Terms related to this study

• Other Study ID Numbers: AK66