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The Effects on Growth of a Non-Routine Infant Formula

This study has been completed.
Sponsor:
Information provided by:
Mead Johnson Nutrition
ClinicalTrials.gov Identifier:
NCT00655720
First received: March 28, 2008
Last updated: April 10, 2008
Last verified: April 2008
  Purpose

A study to evaluate the growth and development of term infants fed either an extensively hydrolyzed formula with probiotics, a partially hydrolyzed formula with probiotics, or an extensively hydrolyzed formula without probiotics


Condition Intervention
Growth
Other: infant formula

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Official Title: The Effects on Growth and Tolerance of Hydrolyzed Formulas Fed to Term Infants

Resource links provided by NLM:


Further study details as provided by Mead Johnson Nutrition:

Primary Outcome Measures:
  • Growth (weight) [ Time Frame: 106 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Tolerance [ Time Frame: 106 days ] [ Designated as safety issue: No ]

Enrollment: 293
Study Start Date: March 2006
Study Completion Date: May 2007
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 Other: infant formula
  1. hydrolyzed infant formula without probiotics
  2. hydrolyzed infant formula with probiotics
  3. hydrolyzed infant formula with probiotics
Other Name: no other names for any of the intervention arms
Experimental: 2 Other: infant formula
  1. hydrolyzed infant formula without probiotics
  2. hydrolyzed infant formula with probiotics
  3. hydrolyzed infant formula with probiotics
Other Name: no other names for any of the intervention arms
Experimental: 3 Other: infant formula
  1. hydrolyzed infant formula without probiotics
  2. hydrolyzed infant formula with probiotics
  3. hydrolyzed infant formula with probiotics
Other Name: no other names for any of the intervention arms

  Eligibility

Ages Eligible for Study:   up to 16 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Term infant
  • Solely formula fed
  • 14 days of age

Exclusion Criteria:

  • History of underlying disease
  • Evidence of formula intolerance
  • Current illness
  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: NCT00655720

Sponsors and Collaborators
Mead Johnson Nutrition
Investigators
Study Director: Deolinda Scalabrin, MD Mead Johnson Nutrition
  More Information

No publications provided by Mead Johnson Nutrition

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Kim Merkel, Mead Johnson
ClinicalTrials.gov Identifier: NCT00655720     History of Changes
Other Study ID Numbers: 3369-5, 3369-5
Study First Received: March 28, 2008
Last Updated: April 10, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Mead Johnson Nutrition:
infant formula

ClinicalTrials.gov processed this record on November 24, 2014