Mechanism of Thrombocytopenia in Infants
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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 |
- 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
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 |
In utero infants who are small for gestational age or who are exposed to maternal pre-eclampsia
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| United States, Delaware | |
| Christiana Care Health Systems | |
| Newark, Delaware, United States, 19713 | |
| Principal Investigator: | Kelly Zook, MD | Christiana Care Health Systems; Thomas Jefferson University Hospital |
More Information
No publications provided
| Responsible Party: | Kelly Zook, MD, Christiana Hospital |
| ClinicalTrials.gov Identifier: | NCT00333333 History of Changes |
| Other Study ID Numbers: | CCC# 26075 |
| Study First Received: | June 2, 2006 |
| Last Updated: | June 12, 2008 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Christiana Care Health Services:
|
Thrombocytopenia Small for Gestational Age (SGA) Preeclampsia |
Additional relevant MeSH terms:
|
Pre-Eclampsia Thrombocytopenia Hypertension, Pregnancy-Induced |
Pregnancy Complications Blood Platelet Disorders Hematologic Diseases |
ClinicalTrials.gov processed this record on May 22, 2013