- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00375908
Umbilical Cord Blood Proteomic Analysis and Neonatal Brain Injury
August 31, 2015 updated by: Ernest M. Graham, M.D., Johns Hopkins University
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.
Study Overview
Status
Completed
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
Enrollment (Actual)
4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Maryland
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Baltimore, Maryland, United States, 21287-1164
- Johns Hopkins Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
This study looked at umbilical cord blood from normal neonates and neonates with risk factors for neurological injury.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Umbilical Cord Blood Proteomic Analysis and Neonatal Brain Injury
Time Frame: 2 years
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ernest M Graham, M.D., Johns Hopkins Medicine, Dept Gyn-Ob
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2005
Primary Completion (Actual)
December 1, 2008
Study Completion (Actual)
December 1, 2008
Study Registration Dates
First Submitted
September 11, 2006
First Submitted That Met QC Criteria
September 11, 2006
First Posted (Estimate)
September 13, 2006
Study Record Updates
Last Update Posted (Estimate)
September 1, 2015
Last Update Submitted That Met QC Criteria
August 31, 2015
Last Verified
August 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Cardiovascular Diseases
- Vascular Diseases
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Wounds and Injuries
- Infant, Newborn, Diseases
- Craniocerebral Trauma
- Trauma, Nervous System
- Signs and Symptoms, Respiratory
- Infant, Premature, Diseases
- Hypoxia, Brain
- Encephalomalacia
- Brain Ischemia
- Ischemia
- Brain Injuries
- Hypoxia
- Hypoxia-Ischemia, Brain
- Leukomalacia, Periventricular
Other Study ID Numbers
- 861
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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