Breast Milk Composition and HIV-exposed/Unexposed Early Infant Growth and Infectious Disease Events

October 30, 2017 updated by: Cornell University
The purpose of this study is to understand how breast milk may protect infants from infection and promote favorable immunological, growth and development outcomes. By following mothers and their infants, we will evaluate the important interactions between infant immune responses and infectious disease events in relation to breast milk composition and feeding patterns. Our aim is to identify a set of predictive factors corresponding to healthy early infant growth and development in this setting in Northern Tanzania.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Anticipated)

208

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Tanzania
      • Kisesa, Tanzania
        • Kisesa Health Centre

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

HIV+ and HIV- mothers and their infants attending a semi-rural clinic and/or rural dispensaries from birth to 6 months of infant age in north western Tanzania.

Description

Inclusion Criteria:

  • Informed consent provided by mothers, and parental consent on behalf of their infants
  • Confirmed maternal HIV status (HIV-1, HIV-2 or HIV-Dual seropositive or HIV-seronegative)
  • Stated intention to remain in the clinic catchment area ≥6 months post-partum
  • Singleton birth

Exclusion Criteria:

  • None

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

Cohorts and Interventions

Group / Cohort
HIV+ and HIV- mothers and their infants

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Breast milk composition
Time Frame: Up to 6 months post-partum
Up to 6 months post-partum

Secondary Outcome Measures

Outcome Measure
Time Frame
Infant anthropometric measures
Time Frame: Up to 6 months of age
Up to 6 months of age
Infant infectious disease events
Time Frame: Up to 6 months of age
Up to 6 months of age

Collaborators and Investigators

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

Sponsor

Cornell University

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 (Actual)

April 1, 2012

Primary Completion (Actual)

June 15, 2013

Study Completion (Actual)

June 30, 2013

Study Registration Dates

First Submitted

October 2, 2012

First Submitted That Met QC Criteria

October 2, 2012

First Posted (Estimate)

October 4, 2012

Study Record Updates

Last Update Posted (Actual)

November 1, 2017

Last Update Submitted That Met QC Criteria

October 30, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB 1111002616

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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