Maternal-fetal CD4 Microchimerism in HiV Exposed Newborns After Spontaneous Delivery and Cesarean Section

February 19, 2016 updated by: Dr. med. Horst Buxmann, Johann Wolfgang Goethe University Hospital

The aim of this single centre study is to measure maternal CD4+ t-cells in HiV exposed Newborns after spontaneous birth in comparison to cesarean section.

This may have an influence on the risk of vertical HiV transmission.

Study Overview

Status

Completed

Conditions

Detailed Description

At birth maternal CD4+ t-cells from umbilical cord blood and placenta blood are measured by microchimerism-analysis.

After 6 weeks the maternal CD4+ t-cells are measured in the blood of the babies blood.

Additionally we look for HiV in maternal CD4+ t-cells.

Study Type

Observational

Enrollment (Actual)

54

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

  • Germany
    • Hesse
      • Frankfurt/Main, Hesse, Germany, 60590
        • Clinic of the Johann Wolfgang-Goethe Univeristy

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

1 minute to 10 minutes (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Approximately 30 HiV exposed newborns born via spontaneuous delivery or cesarean section.

Description

Inclusion Criteria:

• HiV exposed Newborns with normal risk of HiV transmission.

Exclusion Criteria:

  • HiV exposed Newborns wiht elevated or high risk of HiV transmission.
  • HiV exposed Newborns of mothers not full of age.
  • missing informed consent of at least the mother
  • Outborns
  • Asphyxia
  • Major congenital defects
  • Chromosomal anomalies

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
Spontaneous delivery
Approximately 15 HiV exposed Newborns with low HiV transmission risk, born via spontaneous delivery.
Cesarean section
Approximately 15 HiV exposed Newborns with low HiV transmission risk, born via cesarean section.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maternal CD4+ t-cells in HiV exposed Newborns
Time Frame: Six weeks after date of birth
The maternal CD4+ t-cells are measured by microchimersimanalysis
Six weeks after date of birth

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HiV transmission rate
Time Frame: 6 month after birth
Measurement of HiV PCR at the age of 6 month after birth
6 month after birth
Analysis of HiV in maternal CD4+ t-cells
Time Frame: 2 month after delivery
HiV-PCR analysis from maternal CD4+ cells
2 month after delivery
Measurement of maternal CD8+ t-cells in the Newborn
Time Frame: 6 weeks
Measurement of maternal CD8+ t-cells by microchimerismanalysis
6 weeks

Collaborators and Investigators

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

Sponsor

Johann Wolfgang Goethe University Hospital

Investigators

  • Principal Investigator: Horst Buxmann, Dr. med., Johann Wolfgang Goethe University Hospital Frankfurt/Main, Department of Neonatology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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, 2011

Primary Completion (Actual)

April 1, 2014

Study Completion (Actual)

August 1, 2015

Study Registration Dates

First Submitted

October 7, 2011

First Submitted That Met QC Criteria

October 11, 2011

First Posted (Estimate)

October 12, 2011

Study Record Updates

Last Update Posted (Estimate)

February 22, 2016

Last Update Submitted That Met QC Criteria

February 19, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 31082011 FRA Mat Fet Chim

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.

Clinical Trials on Human Immunodeficiency Virus

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in United Arab Emirates

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe