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Ex Vivo Exploratory Analysis in Healthy Full-term Infants

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01573884
First Posted: April 10, 2012
Last Update Posted: April 10, 2012
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.
Information provided by (Responsible Party):
Abbott Nutrition
  Purpose
  • Exploratory analyses of the immune response in a ex vivo culture system
  • Characterization of the composition of maternal milk and infant urine

Condition
Healthy Infant and Mother Pairs

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Ex Vivo Exploratory Analysis in Healthy Full-term Infants

Further study details as provided by Abbott Nutrition:

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

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

Enrollment: 54
Study Start Date: September 2011
Study Completion Date: February 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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 -
  Contacts and Locations
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
  More Information

Responsible Party: Abbott Nutrition
ClinicalTrials.gov Identifier: NCT01573884     History of Changes
Other Study ID Numbers: AK97
First Submitted: April 6, 2012
First Posted: April 10, 2012
Last Update Posted: April 10, 2012
Last Verified: April 2012