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Umbilical Cord Blood Proteomic Analysis and Neonatal Brain Injury

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00375908
Recruitment Status : Completed
First Posted : September 13, 2006
Last Update Posted : September 1, 2015
Sponsor:
Information provided by (Responsible Party):
Ernest M. Graham, M.D., Johns Hopkins University

Tracking Information
First Submitted Date September 11, 2006
First Posted Date September 13, 2006
Last Update Posted Date September 1, 2015
Study Start Date October 2005
Actual Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 31, 2015)
Umbilical Cord Blood Proteomic Analysis and Neonatal Brain Injury [ Time Frame: 2 years ]
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Umbilical Cord Blood Proteomic Analysis and Neonatal Brain Injury
Official Title Umbilical Cord Blood Proteomic Analysis and Neonatal Brain Injury
Brief 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.
Detailed Description We will draw up to 20 ml of umbilical venous blood at the time of delivery from infants born at < 34 weeks gestation, and for any infant born at > 34 weeks suspected to be at risk for neurologic morbidity by having intrapartum chorioamnionitis, nonreassuring fetal heart tracing prior to delivery, or a 5 minute Apgar < 7. For each infant born at > 34 weeks later confirmed to have neurologic morbidity by head ultrasound or EEG we will draw cord blood from a gestational age matched control without intrapartum infection or nonreassuring fetal heart tracing prior to delivery. At the time of delivery an umbilical arterial gas and umbilical venous sample for a type and screen, RPR and hematocrit are routinely drawn. The remainder of the cord blood is discarded. After the routinely done arterial blood gas and umbilical venous blood sample are obtained the remainder of the umbilical cord blood, which would otherwise be discarded, will be collected using a 23 gauge or larger needle into a heparinized tube. The sample will be centrifuged for 10 minutes and the plasma layer separated. The sample will be placed into 1.5 ml eppendorf tubes in 500 ul aliquots. Proteomic techniques including mass spectrometry, 2-dimensional electrophoresis, and chromatography, will be used to analyze the proteome from the brain injured and control groups. Specific proteins will be identified, and differences in expression compared between the 2 groups.
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population This study looked at umbilical cord blood from normal neonates and neonates with risk factors for neurological injury.
Condition
  • Hypoxia-Ischemia, Brain
  • Periventricular Leukomalacia
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: August 31, 2015)
4
Original Enrollment
 (submitted: September 11, 2006)
450
Actual Study Completion Date December 2008
Actual Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Less than 34 weeks gestational age or more than 34 weeks with a risk factor for brain injury such as chorioamnionitis, nonreassuring fetal heart rate tracing, metabolic acidosis, or hypotonia at birth.

Exclusion Criteria:

  • Major congenital or chromosomal abnormalities in fetus
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00375908
Other Study ID Numbers 861
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Ernest M. Graham, M.D., Johns Hopkins University
Study Sponsor Johns Hopkins University
Collaborators Not Provided
Investigators
Principal Investigator: Ernest M Graham, M.D. Johns Hopkins Medicine, Dept Gyn-Ob
PRS Account Johns Hopkins University
Verification Date August 2015