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Umbilical Cord Blood Proteomic Analysis and Neonatal Brain Injury

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clinicaltrials.gov/study/NCT00375908
Is a
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Clinical study
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Clinical Study attributes

NCT Number
NCT003759080
Health Conditions in Trial
Periventricular leukomalacia
Periventricular leukomalacia
0
Trial Recruitment Size
40
Trial Sponsor
Johns Hopkins University
Johns Hopkins University
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Clinical Trial Start Date
2005
0
Primary Completion Date
2008
0
Study Completion Date
2008
0
Clinical Trial Study Type
Observational0
Observational Clinical Trial Type
Case-Control0
Observational Study Perspective
Prospective0
Participating Facility
Johns Hopkins Hospital
Johns Hopkins Hospital
0
Official Name
Umbilical Cord Blood Proteomic Analysis and Neonatal Brain Injury0
Last Updated
September 1, 2015
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Study summary

The investigators propose to compare the proteomic analysis of umbilical venous blood from neonates with brain injury to gestational age matched noninjured controls. After delivery an umbilical arterial gas and a 10 ml umbilical venous sample are obtained, then the remainder of the cord blood is discarded. The investigators plan to use this cord blood that would otherwise be discarded to perform our proteomic analysis. The investigators will use up to 20 ml of cord blood per delivery. This will be a 5 year study during which time the investigators hope to analyze 450 infants at Johns Hopkins Hospital and Bayview Medical Center. The investigators will obtain an umbilical venous sample from infants born at \< 34 weeks gestation. For infants born at \> 34 weeks the investigators will obtain an umbilical venous sample for any infant suspected to be at risk for neurologic injury by having a diagnosis of chorioamnionitis during labor, nonreassuring fetal heart rate tracing at the time of delivery, or a 5 minute Apgar \< 7. For the infants born at \< 34 weeks the brain injured infants will be compared to gestational age matched controls without brain injury. For the infants born at \> 34 weeks, each infant later confirmed to have neurologic morbidity will be compared to a gestational age matched noninjured control. The investigators hope to use proteomic analysis to determine if there are measurable differences in protein expression between the 2 groups.

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