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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02860026
Recruitment Status : Withdrawn (Raw ingredient shortage. Future study start date - TBD)
First Posted : August 9, 2016
Last Update Posted : May 31, 2017
Sponsor:
Information provided by (Responsible Party):
Mead Johnson Nutrition

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Growth Other: Marketed cow's milk-based infant formula Other: Cow's milk-based infant formula with added nutrients Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Other
Official Title: Growth and Tolerance of Healthy Term Infants Fed Cow's Milk-Based Infant Formulas
Study Start Date : October 2016
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : April 2018

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Rate of body weight gain from 14 to 120 days of age [ Time Frame: 3.5 months ]

Secondary Outcome Measures :
  1. Recall of infant formula at each study visit [ Time Frame: Up to 3.5 months ]
  2. Body length measured at each study visit [ Time Frame: Up to 3.5 months ]
  3. Recall of stool characteristics questionnaire measured at each study visit [ Time Frame: Up to 3.5 months ]
  4. Head circumference measured at each study visit [ Time Frame: Up to 3.5 months ]
  5. Recall of gastrointestinal tolerance questionnaire at each study visit [ Time Frame: Up to 3.5 months ]
  6. Medically confirmed adverse events collected throughout the study period [ Time Frame: Up to 3.5 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 14 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

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): NCT02860026


Locations
Show Show 17 study locations
Sponsors and Collaborators
Mead Johnson Nutrition
Investigators
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Study Director: Steven Wu Mead Johnson Nutrition
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Responsible Party: Mead Johnson Nutrition
ClinicalTrials.gov Identifier: NCT02860026    
Other Study ID Numbers: 3388-1
First Posted: August 9, 2016    Key Record Dates
Last Update Posted: May 31, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Nutrients
Growth Substances
Physiological Effects of Drugs