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

Tracking Information

First Received Date ^ICMJE

April 6, 2012

Last Updated Date

April 6, 2012

Start Date ^ICMJE

September 2011

Primary Completion Date

December 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Viral load in cell cultures [ Time Frame: 14 days ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Ex Vivo Exploratory Analysis in Healthy Full-term Infants

Official Title ^ICMJE

Ex Vivo Exploratory Analysis in Healthy Full-term Infants

Brief Summary

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

Detailed Description

Not Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Case-Only
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Non-Probability Sample

Study Population

infant and mother pairs

Condition ^ICMJE

Healthy Infant and Mother Pairs

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

February 2012

Primary Completion Date

December 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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 -

Gender

Both

Ages

up to 17 Days

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01573884

Other Study ID Numbers ^ICMJE

AK97

Has Data Monitoring Committee

Responsible Party

Abbott Nutrition

Study Sponsor ^ICMJE

Abbott Nutrition

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Chair:

Karen Goehring, MS

Abbott Nutrition

Information Provided By

Abbott Nutrition

Verification Date

April 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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