Mechanism of Thrombocytopenia in Infants - Full Text View

Sponsors and Collaborators:	Christiana Care Health Services Cardeza Foundation of Hematologic Research at TJUH; Philadelphia, PA
Information provided by:	Christiana Care Health Services
ClinicalTrials.gov Identifier:	NCT00333333

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

U.S. FDA Resources

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

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. ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples Without DNA

Biospecimen Description:

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

Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00333333

Locations

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

Sponsors and Collaborators

Christiana Care Health Services

Cardeza Foundation of Hematologic Research at TJUH; Philadelphia, PA

Investigators

Principal Investigator:

Kelly Zook, MD

Christiana Care Health Systems; Thomas Jefferson University Hospital

More Information

Responsible Party:	Christiana Hospital ( Kelly Zook, MD )
Study ID Numbers:	CCC# 26075
Study First Received:	June 2, 2006
Last Updated:	June 12, 2008
ClinicalTrials.gov Identifier:	NCT00333333
Health Authority:	United States: Institutional Review Board

Keywords provided by Christiana Care Health Services:

Thrombocytopenia
Small for Gestational Age (SGA)
Preeclampsia

Study placed in the following topic categories:

Thrombocytopathy
Hypertension, Pregnancy-Induced
Pregnancy Complications
Thrombocytopenia
Eclampsia
Hematologic Diseases

Blood Platelet Disorders
Pregnancy toxemia /hypertension
Pre-Eclampsia
Preeclampsia
Hypertension

ClinicalTrials.gov processed this record on January 16, 2009