Ex Vivo Exploratory Analysis in Healthy Full-term Infants

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Abbott Nutrition
ClinicalTrials.gov Identifier:
NCT01573884
First received: April 6, 2012
Last updated: NA
Last verified: April 2012
History: No changes posted
  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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes in viral load and cytokine profiles [ Time Frame: 14 days ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   up to 17 Days
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Abbott Nutrition
ClinicalTrials.gov Identifier: NCT01573884     History of Changes
Other Study ID Numbers: AK97
Study First Received: April 6, 2012
Last Updated: April 6, 2012
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on April 17, 2014