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Mechanism of Thrombocytopenia in Infants

NCT ID: NCT00333333

Last Updated: 2008-06-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-06-30

Study Completion Date

2008-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Thrombocytopenia Small for Gestational Age (SGA) Preeclampsia

Keywords

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Thrombocytopenia Small for Gestational Age (SGA) Preeclampsia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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SGA infants

Infants who are thought to be small for gestational age (SGA)

Cord blood

Intervention Type PROCEDURE

Cord blood will be obtained at the time of delivery.

Pre-eclampsia exposed

Infants who are born to mothers who had pre-eclampsia

Cord blood

Intervention Type PROCEDURE

Cord blood will be obtained at the time of delivery.

Interventions

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Cord blood

Cord blood will be obtained at the time of delivery.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The Cardeza Foundation for Hematologic Research

OTHER

Sponsor Role collaborator

Christiana Care Health Services

OTHER

Sponsor Role lead

Responsible Party

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Christiana Hospital

Principal Investigators

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Kelly Zook, MD

Role: PRINCIPAL_INVESTIGATOR

Christiana Care Health Systems; Thomas Jefferson University Hospital

Locations

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Christiana Care Health Systems

Newark, Delaware, United States

Site Status

Countries

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United States

Other Identifiers

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CCC# 26075

Identifier Type: -

Identifier Source: org_study_id