Mechanism of Thrombocytopenia in Infants

This study has been completed.
Sponsor:
Collaborator:
The Cardeza Foundation for Hematologic Research
Information provided by:
Christiana Care Health Services
ClinicalTrials.gov Identifier:
NCT00333333
First received: June 2, 2006
Last updated: June 12, 2008
Last verified: June 2008
  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

Resource links provided by NLM:


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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
The Cardeza Foundation for Hematologic Research
Investigators
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 July 20, 2014