Infant Immune Response to Bacterial Infection

June 30, 2017 updated by: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Expression Profiling of Bacterial Lipopolysaccharide Activated Neutrophil in Pre-Term, Term Infants and Adults

This study will examine the response of white blood cells to bacterial infection in blood taken from the umbilical cords of newly delivered infants. The blood samples will be taken from both male infants who were carried to term and male infants who were born prematurely, and genetic studies will compare these blood samples to samples drawn from healthy adult male volunteers. The study is designed to look at the ways in which the immune systems of newborn infants respond to bacterial infection.

Participants in this study will be pregnant Chinese women admitted to the labor ward of the Prince of Wales Hospital (Sha Tin district of New Territories, Hong Kong SAR) for normal spontaneous delivery. Those with known blood-borne infectious diseases such as HIV and hepatitis B will be excluded from this study.

Cord blood and placenta samples will be collected after the completion of delivery. The samples collected for this study will be restricted to male newborns. A comparison group of blood samples will be drawn from healthy male adults between 25 and 35 years of age....

Study Overview

Status

Completed

Conditions

Detailed Description

Bacterial infection in preterm neonates is a significant clinical problem. Neutrophils play a critical role in the bactericidal process, which is immature in newborns though their peripheral blood neutrophil counts are similar to or higher than that of older children and adults. The use of steroids to enhance lung maturation in premature infants complicates this problem. Many studies have shown different biological activities between lipopolysaccharide (LPS) activated neonatal cord blood neutrophils and adult peripheral blood neutrophils. In spite of a number of previous studies, the genetic basis of this differential response to LPS-activation remains unknown. In this study, we will identify the differential gene expression profiles of LPS-activated adult peripheral blood versus cord blood neutrophils from both term and preterm infants by whole genome ligonucleotide microarray. We will investigate the priming effect of histologic chorioamnionitis (HCA), a severe infection/inflammation implicated in many neonatal diseases, on the immune response in neutrophils in terms of gene expression. The effect of prenatal administration of steroids on the immune response in preterm neutrophils is another question we will address in the proposed study. This study will provide insight into the molecular basis for genetic regulation of neutrophil development. We expect to identify novel genes with differential expressions in LPS-activated cord blood neutrophils when compared to those of LPS-activated adult cells. Aberrant transcripts due to the priming effect of HCA to the immune response in term neutrophils will also provide insight on the defense mechanism of subsequent exposures to bacterial infection.

This is a collaborative study. All samples will be collected by our Collaborators at the Chinese University of Hong Kong, Hong Kong. We will perform expression profiling in the Laboratory of Clinical Genomics at NICHD. This protocol has been approved by the Joint Clinical Research Ethics Committee of the Chinese University of Hong Kong and Hospital Authority of Hong Kong.

Study Type

Observational

Enrollment (Anticipated)

45

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

  • United States
    • Maryland
      • Bethesda, Maryland, United States, 20892
        • National Institute of Child Health and Human Development (NICHD), 9000 Rockville

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

Description

  • INCLUSION CRITERIA:

Chinese pregnant women admitted to the labor ward of the Prince of Wales hospital.

Normal spontaneous delivery.

EXCLUSION CRITERIA:

Patient diagnosed with known infectious diseases such as HIV and HBV positive cases (blood precautions).

Patients are incompetent to consent such as being mentally retarded or mentally ill and without an impairment of judgment at the time of consenting.

Patients who do not consent.

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

Collaborators and Investigators

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

Sponsor

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

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

October 15, 2007

Study Completion

March 29, 2011

Study Registration Dates

First Submitted

October 17, 2007

First Submitted That Met QC Criteria

October 17, 2007

First Posted (Estimate)

October 18, 2007

Study Record Updates

Last Update Posted (Actual)

July 2, 2017

Last Update Submitted That Met QC Criteria

June 30, 2017

Last Verified

March 29, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 999908011
  • 08-CH-N011

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 Prematurity

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in South Africa

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe