Mechanism of Thrombocytopenia in Infants

June 12, 2008 updated by: Christiana Care Health Services

Mechanism of Thrombocytopenia in Small for Gestational Age Infants Versus Infants With Maternal Preeclampsia Exposure

This research project is studying the causes for low platelet levels in preterm infants. Platelets are a component of blood that helps with clotting. The purpose of this study is to determine whether the cause for low platelet levels is the same in infants who are born to mothers with preeclampsia and infants who are small for gestational age.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Thrombocytopenia is a common entity in infants who are born to mothers with preeclampsia and in infants who are small for gestational age. There have been several theories to the mechanism underlying thrombocytopenia in these groups of patients. One mechanism suggests that thrombocytopenia in these populations may be secondary to underproduction of platelets. Other studies have implied that low platelet levels may be due to endothelial activation causing platelet consumption. This study is being performed to help determine the mechanism causing thrombocytopenia in infants born to mothers with preeclampsia and comparing it to the mechanism of thrombocytopenia in infants who are small for gestational age.

Study Type

Observational

Enrollment (Anticipated)

30

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
    • Delaware
      • Newark, Delaware, United States, 19713
        • Christiana Care Health Systems

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

In utero infants who are small for gestational age or who are exposed to maternal pre-eclampsia

Description

Inclusion Criteria:

  • Infants who are less than 34 weeks gestation
  • Infants born to mothers with preeclampsia
  • Infants who are born small for gestational age whose mother did not have preeclampsia

Exclusion Criteria:

  • Infants who are greater than 34 weeks gestation
  • Infants with known congenital anomalies or known congenital infections

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
Intervention / Treatment
SGA infants
Infants who are thought to be small for gestational age (SGA)
Procedure: Cord blood
Cord blood will be obtained at the time of delivery.
Pre-eclampsia exposed
Infants who are born to mothers who had pre-eclampsia
Procedure: Cord blood
Cord blood will be obtained at the time of delivery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To determine the mechanism of thrombocytopenia in small for gestational age infants versus infants with maternal preeclampsia exposure
Time Frame: Each infant will only be enrolled during the time of birth until cord blood is collected.
Each infant will only be enrolled during the time of birth until cord blood is collected.

Collaborators and Investigators

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

Sponsor

Christiana Care Health Services

Collaborators

The Cardeza Foundation for Hematologic Research

Investigators

  • Principal Investigator: Kelly Zook, MD, Christiana Care Health Systems; Thomas Jefferson University Hospital

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

June 1, 2006

Primary Completion (Actual)

March 1, 2008

Study Completion (Actual)

June 1, 2008

Study Registration Dates

First Submitted

June 2, 2006

First Submitted That Met QC Criteria

June 2, 2006

First Posted (Estimate)

June 5, 2006

Study Record Updates

Last Update Posted (Estimate)

June 13, 2008

Last Update Submitted That Met QC Criteria

June 12, 2008

Last Verified

June 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCC# 26075

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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