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Ex Vivo Exploratory Analysis in Healthy Full-term Infants

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ClinicalTrials.gov Identifier: NCT01573884
Recruitment Status : Completed
First Posted : April 10, 2012
Last Update Posted : April 10, 2012
Sponsor:
Information provided by (Responsible Party):
Abbott Nutrition

Brief Summary:
  • Exploratory analyses of the immune response in a ex vivo culture system
  • Characterization of the composition of maternal milk and infant urine

Condition or disease
Healthy Infant and Mother Pairs

Study Type : Observational
Actual Enrollment : 54 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Ex Vivo Exploratory Analysis in Healthy Full-term Infants
Study Start Date : September 2011
Actual Primary Completion Date : December 2011
Actual Study Completion Date : February 2012



Primary Outcome Measures :
  1. Viral load in cell cultures [ Time Frame: 14 days ]

Secondary Outcome Measures :
  1. Changes in viral load and cytokine profiles [ Time Frame: 14 days ]


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Ages Eligible for Study:   up to 17 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
infant and mother pairs
Criteria

Inclusion Criteria

  • Infant or infant-mother pair in good health
  • Infant or infant-mother pair is from smoke-free home
  • Infant is a singleton, full term
  • birth weight was > 2490 g
  • Between 0 and 17 days of age at enrollment
  • Human milk fed infants must have been exclusively human milk-fed since birth; formula fed infants must have received Similac Advance or Similac Sensitive since birth
  • Parents confirm their intention not to administer vitamin or mineral supplements (excluding vitamin or mineral supplements containing vitamin D), solid foods or juices to their infant from enrollment throughout the study

Exclusion Criteria:

  • An adverse maternal, fetal or infant medical history, including gestational diabetes that is thought by the investigator to have potential for effects on tolerance, growth, and/or development.
  • Infant has been treated with antibiotics
  • Participation in another study -

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): NCT01573884


Locations
United States, Indiana
Northpoint Pediatrics
Indianapolis, Indiana, United States, 46256
United States, Ohio
Institute of Clinical Research
Mayfield Heights, Ohio, United States, 44124
Sponsors and Collaborators
Abbott Nutrition
Investigators
Study Chair: Karen Goehring, MS Abbott Nutrition

Responsible Party: Abbott Nutrition
ClinicalTrials.gov Identifier: NCT01573884     History of Changes
Other Study ID Numbers: AK97
First Posted: April 10, 2012    Key Record Dates
Last Update Posted: April 10, 2012
Last Verified: April 2012