Growth and Tolerance of Healthy Term Infants Fed Cow's Milk-Based Infant Formulas

This clinical trial will compare the growth and tolerance of infants who consume an investigational cow's milk-based infant formula to those who consume a marketed cow's milk-based infant formula through approximately 4 months of age.

Study Overview

• Status: Withdrawn
• Conditions: Growth
• Intervention / Treatment: Other: Marketed cow's milk-based infant formula; Other: Cow's milk-based infant formula with added nutrients

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35205
      • Birmingham Pediatric Associates
    • Dothan, Alabama, United States, 36305
      • Southeastern Pediatric Associates
  • Arkansas
    • Fayetteville, Arkansas, United States, 72703
      • Northwest Arkansas Pediatric Clinic
    • Jonesboro, Arkansas, United States, 72401
      • The Children's Clinic of Jonesboro, P.A.
  • Connecticut
    • Norwich, Connecticut, United States, 06360
      • Norwich Pediatric Group, P.C.
  • Florida
    • Lake Mary, Florida, United States, 32746
      • Altamonte Pediatric Associates
  • Indiana
    • Evansville, Indiana, United States, 47725
      • Deaconess Clinical Research
  • Kentucky
    • Bardstown, Kentucky, United States, 40004
      • Kentucky Pediatrics/Adult Research
    • Owensboro, Kentucky, United States, 42303
      • Owensboro Pediatrics
  • Ohio
    • Cincinnati, Ohio, United States, 45245
      • Pediatric Associates of Mt. Carmel, Inc.
    • Dayton, Ohio, United States, 45414
      • Ohio Pediatric Research Association
    • Fairfield, Ohio, United States, 45014
      • Pediatric Associates of Fairfield, Inc.
    • Westlake, Ohio, United States, 44145
      • UHMP Comprehensive Pediatrics
  • South Carolina
    • Charleston, South Carolina, United States, 29414
      • Coastal Pediatric Research
  • Tennessee
    • Jackson, Tennessee, United States, 38305
      • The Jackson Clinic - North Jackson
    • Kingsport, Tennessee, United States, 37660
      • Holston Medical Group
  • Texas
    • Longview, Texas, United States, 75605
      • DCOL Center for Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 week to 2 weeks (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Singleton 10-14 days of age at randomization
• Term infant with birth weight of minimum of 2500 grams
• Solely formula fed
• Signed informed consent and protected health information

Exclusion Criteria:

• History of underlying metabolic or chronic disease, anemia, or immune compromise
• Feeding difficulties or formula intolerance

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control; Marketed cow's milk-based infant formula	Other: Marketed cow's milk-based infant formula
Experimental: Investigational; Cow's milk-based infant formula with added nutrients	Other: Cow's milk-based infant formula with added nutrients

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Rate of body weight gain from 14 to 120 days of age	3.5 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Recall of infant formula at each study visit	Up to 3.5 months
Body length measured at each study visit	Up to 3.5 months
Recall of stool characteristics questionnaire measured at each study visit	Up to 3.5 months
Head circumference measured at each study visit	Up to 3.5 months
Recall of gastrointestinal tolerance questionnaire at each study visit	Up to 3.5 months
Medically confirmed adverse events collected throughout the study period	Up to 3.5 months

Collaborators and Investigators

• Sponsor: Mead Johnson Nutrition

Study record dates

Study Major Dates

• Study Start: October 1, 2016
• Primary Completion (Anticipated): March 1, 2018
• Study Completion (Anticipated): April 1, 2018

Study Registration Dates

• First Submitted: August 3, 2016
• First Submitted That Met QC Criteria: August 4, 2016
• First Posted (Estimate): August 9, 2016

Study Record Updates

• Last Update Posted (Actual): May 31, 2017
• Last Update Submitted That Met QC Criteria: May 26, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: 3388-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No