Mechanism of Thrombocytopenia in Infants

Preeclampsia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00333333
• Other study ID #: CCC# 26075
• Status: Completed
• Phase: N/A
• First received: June 2, 2006
• Last updated: June 12, 2008
• Start date: June 2006
• Est. completion date: June 2008

Study information

• Verified date: June 2008
• Source: Christiana Care Health Services
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Pre-Eclampsia
• Preeclampsia
• Small for Gestational Age (SGA)
• Thrombocytopenia
• Thrombocytosis

Intervention

Procedure:
• Cord blood
Cord blood will be obtained at the time of delivery.

Locations

Country	Name	City	State
United States	Christiana Care Health Systems	Newark	Delaware

Sponsors (2)

Lead Sponsor	Collaborator
Christiana Care Health Services	The Cardeza Foundation for Hematologic Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the mechanism of thrombocytopenia in small for gestational age infants versus infants with maternal preeclampsia exposure		Each infant will only be enrolled during the time of birth until cord blood is collected.	No