Mechanism of Thrombocytopenia in Infants

NCT00333333 | Completed

• 1 other identifier: CCC# 26075
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Thrombocytopenia; Small for Gestational Age (SGA); Preeclampsia

Keywords

Thrombocytopenia; Small for Gestational Age (SGA); Preeclampsia

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

SGA infants

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

Procedure: Cord blood

Pre-eclampsia exposed

Infants who are born to mothers who had pre-eclampsia

Procedure: Cord blood

Interventions

Cord blood PROCEDURE

Cord blood will be obtained at the time of delivery.

Pre-eclampsia exposed; SGA infants

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

In utero infants who are small for gestational age or who are exposed to maternal pre-eclampsia

You may qualify if:

• 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

You may not qualify if:

• Infants who are greater than 34 weeks gestation
• Infants with known congenital anomalies or known congenital infections

Sponsors & Collaborators

• Christiana Care Health Services: lead
• The Cardeza Foundation for Hematologic Research: collaborator

Study Sites (1)

Christiana Care Health Systems

Newark, Delaware, 19713, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Cord blood

MeSH Terms

Conditions

Thrombocytopenia; Pre-Eclampsia

Condition Hierarchy (Ancestors)

Blood Platelet Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Cytopenia; Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Kelly Zook, MD

  Christiana Care Health Systems; Thomas Jefferson University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 2, 2006
• First Posted: June 5, 2006
• Study Start: June 1, 2006
• Primary Completion: March 1, 2008
• Study Completion: June 1, 2008
• Last Updated: June 13, 2008

Record last verified: 2008-06

Locations

US (1)