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Mechanism of Thrombocytopenia in Infants

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00333333
First Posted: June 5, 2006
Last Update Posted: June 13, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
The Cardeza Foundation for Hematologic Research
Information provided by:
Christiana Care Health Services
  Purpose
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.

Condition Intervention
Thrombocytopenia Small for Gestational Age (SGA) Preeclampsia Procedure: Cord blood

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Mechanism of Thrombocytopenia in Small for Gestational Age Infants Versus Infants With Maternal Preeclampsia Exposure

Resource links provided by NLM:


Further study details as provided by Christiana Care Health Services:

Primary Outcome Measures:
  • 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. ]

Biospecimen Retention:   Samples Without DNA
Cord blood

Estimated Enrollment: 30
Study Start Date: June 2006
Study Completion Date: June 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
In utero infants who are small for gestational age or who are exposed to maternal pre-eclampsia
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00333333


Locations
United States, Delaware
Christiana Care Health Systems
Newark, Delaware, United States, 19713
Sponsors and Collaborators
Christiana Care Health Services
The Cardeza Foundation for Hematologic Research
Investigators
Principal Investigator: Kelly Zook, MD Christiana Care Health Systems; Thomas Jefferson University Hospital
  More Information

Responsible Party: Kelly Zook, MD, Christiana Hospital
ClinicalTrials.gov Identifier: NCT00333333     History of Changes
Other Study ID Numbers: CCC# 26075
First Submitted: June 2, 2006
First Posted: June 5, 2006
Last Update Posted: June 13, 2008
Last Verified: June 2008

Keywords provided by Christiana Care Health Services:
Thrombocytopenia
Small for Gestational Age (SGA)
Preeclampsia

Additional relevant MeSH terms:
Thrombocytopenia
Pre-Eclampsia
Blood Platelet Disorders
Hematologic Diseases
Hypertension, Pregnancy-Induced
Pregnancy Complications