Hypoxia-Ischemia, BrainNCT00375908
Umbilical Cord Blood Proteomic Analysis and Neonatal Brain Injury
An observational study of Hypoxia-Ischemia, Brain and Periventricular Leukomalacia, run by Johns Hopkins University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hypoxia-Ischemia, Brain, Periventricular Leukomalacia
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2005to Dec 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: This study looked at umbilical cord blood from normal neonates and neonates with risk factors for neurological injury.
Who may be able to join
- 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.
Who cannot join
- Major congenital or chromosomal abnormalities in fetus
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins Hospital
Baltimore, Maryland, 21287-1164
About this study
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.
Read the 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.
- Keywords
- Neonatal Encephalopathy, Hypoxic-Ischemic Brain Injury, Umbilical Cord Blood, Proteomics
- Medical subject headings
- Hypoxia-Ischemia, Brain, Leukomalacia, Periventricular
What is being measured
The primary outcome is the main question the study is designed to answer.
Umbilical Cord Blood Proteomic Analysis and Neonatal Brain Injury
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2006 (estimated)
- Study startOct 2005
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypoxia-Ischemia, BrainStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ernest M. Graham, M.D., Johns Hopkins University
- Investigators
- Ernest M Graham, M.D., Principal investigator, Johns Hopkins Medicine, Dept Gyn-Ob
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00375908
- Sponsor's protocol ID
- 861
- Status last verified
- Aug 2015
- First submitted
- 11 Sep 2006
- Last updated
- 1 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Umbilical Cord Blood Proteomic Analysis and Neonatal Brain Injury
- ClinicalTrials.gov ID
- NCT00375908
- Acronym / sponsor ID
- 861
- Keywords
- Neonatal Encephalopathy, Hypoxic-Ischemic Brain Injury, Umbilical Cord Blood, Proteomics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- Oct 2005
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 13 Sep 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This study looked at umbilical cord blood from normal neonates and neonates with risk factors for neurological injury.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Major congenital or chromosomal abnormalities in fetus
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Umbilical Cord Blood Proteomic Analysis and Neonatal Brain Injury
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ernest M Graham, M.D. principal investigator
Johns Hopkins Medicine, Dept Gyn-Ob
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypoxia-Ischemia, Brain and Periventricular Leukomalacia, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Umbilical Cord Blood Proteomic Analysis and Neonatal Brain Injury (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2015.