Umbilical Cord Blood Proteomic Analysis and Neonatal Brain Injury

This study has been completed.
Sponsor:
Information provided by:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00375908
First received: September 11, 2006
Last updated: August 19, 2009
Last verified: August 2009
  Purpose

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.


Condition
Hypoxia-Ischemia, Brain
Periventricular Leukomalacia
Umbilical Cord Blood
Proteomics

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Umbilical Cord Blood Proteomic Analysis and Neonatal Brain Injury

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Enrollment: 12
Study Start Date: October 2005
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

This study looked at umbilical cord blood from normal neonates and neonates with risk factors for neurological injury.

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00375908

Locations
United States, Maryland
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287-1164
Sponsors and Collaborators
Johns Hopkins University
Investigators
Principal Investigator: Ernest M Graham, M.D. Johns Hopkins Medicine, Dept Gyn-Ob
  More Information

No publications provided

Responsible Party: Ernie Graham, M.D., Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00375908     History of Changes
Other Study ID Numbers: 861
Study First Received: September 11, 2006
Last Updated: August 19, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Johns Hopkins University:
Neonatal Encephalopathy
Hypoxic-Ischemic Brain Injury
Umbilical Cord Blood
Proteomics

Additional relevant MeSH terms:
Brain Ischemia
Ischemia
Leukomalacia, Periventricular
Anoxia
Brain Injuries
Hypoxia-Ischemia, Brain
Wounds and Injuries
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Encephalomalacia
Infant, Premature, Diseases
Infant, Newborn, Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Craniocerebral Trauma
Trauma, Nervous System
Hypoxia, Brain

ClinicalTrials.gov processed this record on September 15, 2014