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Completed

NCT Number: NCT00333333

Mechanism of Thrombocytopenia in Infants

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.

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Key information

Conditions

Thrombocytopenia Blood Platelet Disorders Cytopenia Female Urogenital Diseases and Pregnancy Complications Hematologic Diseases Hemic and Lymphatic Diseases Hypertension, Pregnancy-Induced Pre-Eclampsia Preeclampsia Pregnancy Complications Small For Gestational Age (SGA) Urogenital Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Christiana Care Health Systems

Newark, Delaware, 19713, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cord blood

Procedure

Cord blood will be obtained at the time of delivery.

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Christiana Care Health Services

Other

Collaborators

  • The Cardeza Foundation for Hematologic Research

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Jun 5, 2006
Registry last updated
Jun 13, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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