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

March 13, 2023 updated by: Mead Johnson Nutrition
This study is an evaluation of the composition of human milk and health outcomes in children.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

245

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 2 years (Child)

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Children up to 2 years of age

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
2 years of age

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 years of age
anthropometric measurements
Time Frame: 2 years of age
participants' weight, length and head circumference
2 years of age
Incidence of anemia in first 2 years of age
Time Frame: 2 years of age
Hemoglobulin measurement
2 years of age

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mead Johnson Nutrition

Investigators

  • Principal Investigator: Hugo Ribeiro, Jr, M.D., Federal University of Bahia School of Nutrition

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2010

Primary Completion (Actual)

June 1, 2012

Study Completion (Actual)

June 1, 2012

Study Registration Dates

First Submitted

June 7, 2011

First Submitted That Met QC Criteria

September 8, 2011

First Posted (Estimate)

September 9, 2011

Study Record Updates

Last Update Posted (Actual)

March 14, 2023

Last Update Submitted That Met QC Criteria

March 13, 2023

Last Verified

May 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 6010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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