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Evaluation of the Composition of Human Milk and Health Outcomes in Children

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01431482
First Posted: September 9, 2011
Last Update Posted: May 3, 2013
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):
Mead Johnson Nutrition
  Purpose
This study is an evaluation of the composition of human milk and health outcomes in children.

Condition
Respiratory Symptoms Signs and Symptoms, Digestive Anemia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of the Composition of Human Milk and Health Outcomes in Children

Further study details as provided by Mead Johnson Nutrition:

Primary Outcome Measures:
  • Incidence of infectious and allergic Gastrointestinal events through 2 years of age [ Time Frame: 2 years of age ]
    Number of incidences of infectious and allergic Gastrointestinal events for each participant through 2 years of age


Secondary Outcome Measures:
  • Incidence of infectious and allergic respiratory events through 2 years of age [ Time Frame: 2 years of age ]
    Number of incidences of infectious and allergic respiratory events for each participant through 2 years of age

  • anthropometric measurements [ Time Frame: 2 years of age ]
    participants' weight, length and head circumference

  • Incidence of anemia in first 2 years of age [ Time Frame: 2 years of age ]
    Hemoglobulin measurement


Biospecimen Retention:   Samples Without DNA
Human milk samples

Enrollment: 245
Study Start Date: August 2010
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 2 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Children up to 2 years of age
Criteria

Inclusion Criteria:

  • Human milk samples from mothers from a larger birth co-hort study
  • Health outcomes of children from mothers from a larger birth co-hort study from birth through two years of age
  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): NCT01431482


Sponsors and Collaborators
Mead Johnson Nutrition
Investigators
Principal Investigator: Hugo Ribeiro, Jr, M.D. Federal University of Bahia School of Nutrition
  More Information

Responsible Party: Mead Johnson Nutrition
ClinicalTrials.gov Identifier: NCT01431482     History of Changes
Other Study ID Numbers: 6010
First Submitted: June 7, 2011
First Posted: September 9, 2011
Last Update Posted: May 3, 2013
Last Verified: May 2013

Keywords provided by Mead Johnson Nutrition:
skin symptoms

Additional relevant MeSH terms:
Signs and Symptoms
Signs and Symptoms, Respiratory
Signs and Symptoms, Digestive