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

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ClinicalTrials.gov Identifier: NCT01431482
Recruitment Status : Completed
First Posted : September 9, 2011
Last Update Posted : May 3, 2013
Sponsor:
Information provided by (Responsible Party):
Mead Johnson Nutrition

Brief Summary:
This study is an evaluation of the composition of human milk and health outcomes in children.

Condition or disease
Respiratory Symptoms Signs and Symptoms, Digestive Anemia

Study Type : Observational
Actual Enrollment : 245 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of the Composition of Human Milk and Health Outcomes in Children
Study Start Date : August 2010
Actual Primary Completion Date : June 2012
Actual Study Completion Date : June 2012



Primary Outcome Measures :
  1. 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 :
  1. 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

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

  3. 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


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

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

Responsible Party: Mead Johnson Nutrition
ClinicalTrials.gov Identifier: NCT01431482     History of Changes
Other Study ID Numbers: 6010
First Posted: September 9, 2011    Key Record Dates
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