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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Signs and Symptoms
Signs and Symptoms, Respiratory
Signs and Symptoms, Digestive

ClinicalTrials.gov processed this record on October 19, 2014