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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mead Johnson Nutrition
ClinicalTrials.gov Identifier:
NCT01431482
First received: June 7, 2011
Last updated: May 1, 2013
Last verified: May 2013
  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

Resource links provided by NLM:


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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    participants' weight, length and head circumference

  • Incidence of anemia in first 2 years of age [ Time Frame: 2 years of age ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   up to 2 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01431482

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

No publications provided

Responsible Party: Mead Johnson Nutrition
ClinicalTrials.gov Identifier: NCT01431482     History of Changes
Other Study ID Numbers: 6010
Study First Received: June 7, 2011
Last Updated: May 1, 2013
Health Authority: Brazil: Federal University of Bahia School of Nutrition IRB

Keywords provided by Mead Johnson Nutrition:
skin symptoms

Additional relevant MeSH terms:
Anemia
Signs and Symptoms
Signs and Symptoms, Digestive
Signs and Symptoms, Respiratory
Hematologic Diseases

ClinicalTrials.gov processed this record on April 16, 2014