Mechanism of Thrombocytopenia in Infants

Completed

• Conditions: Small for Gestational Age (SGA); Thrombocytopenia; Preeclampsia
• Interventions: Procedure: Cord blood

• Registration Number: NCT00333333
• Lead Sponsor: Christiana Care Health Services

Brief 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.

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 Timeline

• Study Start: 2006-06
• Study First Submitted: 2006-06-02
• Study First Submitted QC: 2006-06-02
• Study First Posted: 2006-06-05
• Primary Completion: 2008-03
• Status Verified: 2008-06
• Study Completion: 2008-06
• Last Update Submitted: 2008-06-12
• Last Update Posted: 2008-06-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
SGA infants	Cord blood	Infants who are thought to be small for gestational age (SGA)
Pre-eclampsia exposed	Cord blood	Infants who are born to mothers who had pre-eclampsia

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Christiana Care Health Systems; 🇺🇸 Newark, Delaware, United States