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Growth and Tolerance of Cow Milk-Based Infant Formulas

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ClinicalTrials.gov Identifier: NCT01122654
Recruitment Status : Completed
First Posted : May 13, 2010
Last Update Posted : January 31, 2012
Sponsor:
Information provided by:
Mead Johnson Nutrition

Brief Summary:
This clinical trial will assess growth, tolerance and adverse events of cow milk-based infant formulas in healthy, term infants.

Condition or disease
Body Weight

Study Type : Observational
Estimated Enrollment : 405 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Growth and Tolerance of Cow Milk-Based Infant Formulas
Study Start Date : July 2010
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine


Group/Cohort
Control
Experimental 1
Experimental 2



Primary Outcome Measures :
  1. Body weight measured on calibrated infant scale at each study visit

Secondary Outcome Measures :
  1. Twenty-four hour recall of infant formula intake at each study visit
  2. Medically-confirmed adverse events collected throughout the study period
  3. Twenty-four hour recall of stool characteristics (number and consistency) and tolerance at each study visit
  4. Parental Product Assessment Questionnaire completed at Study Visit 2
    Assessment of physical properties of product and infant's reaction during consumption.

  5. Body Length and Head Circumference measured at each study visit


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 16 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Healthy, term infants
Criteria

Inclusion Criteria:

  • Singleton, 12-16 days of age at randomization
  • Term infant with birth weight of minimum of 2500 g
  • Solely formula fed
  • Signed Informed Consent and Protected Health Information

Exclusion Criteria:

  • History of underlying metabolic or chronic disease or immunocompromised
  • Acute infection
  • Feeding difficulties or formula intolerance

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01122654


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Sponsors and Collaborators
Mead Johnson Nutrition

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Tim Cooper, M.D., Mead Johnson Nutrition
ClinicalTrials.gov Identifier: NCT01122654     History of Changes
Other Study ID Numbers: 3380-1
First Posted: May 13, 2010    Key Record Dates
Last Update Posted: January 31, 2012
Last Verified: January 2012

Additional relevant MeSH terms:
Body Weight
Signs and Symptoms