Congenital DisordersNCT00490295
Biomarkers for Detection of Brain Ischemia
An observational study of Congenital Disorders, run by Emory University at 1 site in United States.
Trial summary
Brain injury occurs in one-quarter to one-half of congenital heart defect infants during the perioperative period. A blood test using a biomarker to diagnose brain injury would be important. Read more about this study
- Who is it for?
- Ages 1 day to 30 days
- Conditions the study is for
- Congenital Disorders
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2008to Jan 2010
- 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 1 day to 30 days
- All sexes
- No healthy volunteers
- Child
Study population: Ten consecutive full-term (>36 week gestation) neonates, one day to 30 days of age, presenting for cardiac surgery for arterial switch operation or Norwood operation will be eligible for the study
Who may be able to join
- Ten consecutive full-term (>36 week gestation) neonates, one day to 30 days of age, presenting for cardiac surgery for arterial switch operation or Norwood operation will be eligible for the study.
- No patient will be excluded because of race or ethnicity.
- Parental or legal guardian consent will be obtained for all patients prior to enrollment.
Who cannot join
- Newborns with multiple organ abnormalities in addition to their heart defect such as diaphragmatic hernia, tracheo-esophageal fistula, and congenital syndromes involving multiple organs will be excluded from participation.
- Newborns with genetic syndromes associated with developmental delay will also be excluded.
- Newborns with birth asphyxia, 5 minute Apgar score < 5, will be excluded. Patients with multiple organ failure, syndromes, and birth asphyxia have other causes for neurodevelopmental abnormalities.
- Those patients unable to return for postop follow-up and neurodevelopmental testing will be excluded from participation.
- Those patients with parents/guardians who are unable to read or speak English will be excluded from participation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Biomarkers for the Detection of Brain Ischemia in Neonates With Congenial Heart Disease Requiring Cardiac Surgery
Brain injury occurs in one-quarter to one-half of congenital heart defect infants during the perioperative period. A blood test using a biomarker to diagnose brain injury would be important.
Postoperative cerebral ischemia may be decreased by inotropic support, ventilation, medical management aimed at increasing oxygen delivery to the brain. Currently there are no FDA approved blood tests to assess brain ischemia in infants undergoing cardiac surgery.
Read more
Specific Aim 1: We will prospectively study 10 neonates (< 30 days of age) undergoing cardiac surgery utilizing cardiopulmonary bypass for arterial switch operation or Norwood operation to determine the specificity and sensitivity of a blood test for brain injury. This aim will be accomplished by analyzing blood samples for S-100 and NSE drawn prior to surgery, once each day following cardiac surgery as long as the patient remains in the intensive care unit (maximum 5 days)and at the time of postoperative brain magnetic resonance imaging. The S-100B and NSE values will then be correlated with brain magnetic resonance imaging studies before cardiac surgery and at following cardiac surgery.
Hypothesis: We expect the concentration of S-100B and NSE will be significantly higher in the blood of neonates with congenital heart disease who have documented brain injury on brain magnetic resonance imaging (MRI). Furthermore, we predict that the blood levels of S-100B and NSE may correlate to clinical outcome (time to extubation, hospital discharge, neurodevelopmental outcome at 6 months of age).
Specific Aim 2: We will prospectively study these neonates at 6 months following cardiac surgery to determine a correlation between neurodevelopment and concentration of S-100B and NSE. To achieve this specific aim, a blood sample for S-100B and NSE and neurodevelopmental testing will be done at 6 months following cardiac surgery.
Hypothesis: We expect neonates with elevated S-100B and NSE and abnormal brain magnetic resonance imaging documented in specific aim 1 to have a significant decline in neurodevelopment at 6 months after cardiac surgery.
Long-term: The long-term goal of this research is to diagnose brain ischemia in infants using a biomarker blood test.
Read the detailed description
- Ten full-term neonates (> 36 week gestation), between 1-30 days of age, who present for arterial switch operation or Norwood operation will have 2 ml of blood drawn prior to cardiac surgery, 2 ml blood drawn each day after cardiac surgery as long as the patient remains in the intensive care unit with indwelling lines (maximum of 5 days) and 2 ml blood drawn on the day of the followup brain magnetic resonance imaging study (if not within the maximum of 5 days) to determine blood concentrations S100B and NSE.
- Brain magnetic resonance imaging (MRI) including T1, 2, DWI, spectroscopy, and magnetic resonance angiography, will be performed prior to cardiac surgery and following cardiac surgery in all study patients. Timing of the follow-up brain magnetic resonance imaging including T1, 2, DWI, spectroscopy, and magnetic resonance angiography, will be based on stability of the patient as assessed by the attending physician. Optimal timing for brain magnetic resonance imaging is 4 days postop.
- Maternal information including level of education, medications, and medical history will be obtained. Two mls of blood will also be obtained from the mother to determine maternal blood concentrations of S100B and NSE.
- Study patient clinical variables, including vital signs (heart rate, blood pressure, respiratory rate), systemic oxygen saturation by extremity pulse oximetry, near infrared spectroscopy (NIRS), routine laboratory values will be obtained at the time of each study blood sample.
- Operative variables including cardiopulmonary bypass time, aortic cross clamp time, circulatory arrest time, and hematocrit on bypass will be obtained. Transfusion quantity of packed red blood cells, fresh frozen plasma, platelets, and cryoprecipitate used in the operating room and in the cardiac intensive care unit will also be obtained
- Outcome variables including length of mechanical ventilation, hospital stay, and gross neurological abnormalities (clinical seizures) will be obtained. Follow-up:
- All patients will have neurodevelopmental testing at 6 months after heart surgery.
- Another 2 mls of blood S100B and NSE will be obtained when the patient returns at 6 months for neurodevelopmental testing.
- Conditions
- Congenital Disorders
- Keywords
- biomarkers, brain ischemia, neonates, cardiac surgery, congenital heart disease
- Medical subject headings
- Congenital, Hereditary, and Neonatal Diseases and Abnormalities, Brain Ischemia, Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| newborn cardiac surgical study group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnose brain ischemia in infants using a biomarker blood test.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2007 (estimated)
- Study startMar 2008
- Primary completionJan 2010
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital DisordersStudies of the same condition, open and under way.
- More trials run by Emory 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Healthcare of Atlanta
- Responsible party
- Principal investigator, William T. Mahle, MD, Emory University
- Investigators
- Janet M Simsic, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00490295
- Sponsor's protocol ID
- IRB00002572
- Status last verified
- Nov 2013
- First submitted
- 20 Jun 2007
- Last updated
- 27 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarkers for the Detection of Brain Ischemia in Neonates With Congenial Heart Disease Requiring Cardiac Surgery
- ClinicalTrials.gov ID
- NCT00490295
- Acronym / sponsor ID
- IRB00002572
- Conditions
- Congenital Disorders
- Keywords
- biomarkers, brain ischemia, neonates, cardiac surgery, congenital heart disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- Children's Healthcare of Atlanta
- Study start
- Mar 2008
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 22 Jun 2007 (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.
Brain injury occurs in one-quarter to one-half of congenital heart defect infants during the perioperative period. A blood test using a biomarker to diagnose brain injury would be important.
Postoperative cerebral ischemia may be decreased by inotropic support, ventilation, medical management aimed at increasing oxygen delivery to the brain. Currently there are no FDA approved blood tests to assess brain ischemia in infants undergoing cardiac surgery.
Specific Aim 1: We will prospectively study 10 neonates (< 30 days of age) undergoing cardiac surgery utilizing cardiopulmonary bypass for arterial switch operation or Norwood operation to determine the specificity and sensitivity of a blood test for brain injury. This aim will be accomplished by analyzing blood samples for S-100 and NSE drawn prior to surgery, once each day following cardiac surgery as long as the patient remains in the intensive care unit (maximum 5 days)and at the time of postoperative brain magnetic resonance imaging. The S-100B and NSE values will then be correlated with brain magnetic resonance imaging studies before cardiac surgery and at following cardiac surgery.
Hypothesis: We expect the concentration of S-100B and NSE will be significantly higher in the blood of neonates with congenital heart disease who have documented brain injury on brain magnetic resonance imaging (MRI). Furthermore, we predict that the blood levels of S-100B and NSE may correlate to clinical outcome (time to extubation, hospital discharge, neurodevelopmental outcome at 6 months of age).
Specific Aim 2: We will prospectively study these neonates at 6 months following cardiac surgery to determine a correlation between neurodevelopment and concentration of S-100B and NSE. To achieve this specific aim, a blood sample for S-100B and NSE and neurodevelopmental testing will be done at 6 months following cardiac surgery.
Hypothesis: We expect neonates with elevated S-100B and NSE and abnormal brain magnetic resonance imaging documented in specific aim 1 to have a significant decline in neurodevelopment at 6 months after cardiac surgery.
Long-term: The long-term goal of this research is to diagnose brain ischemia in infants using a biomarker blood test.
Detailed description
- Ten full-term neonates (> 36 week gestation), between 1-30 days of age, who present for arterial switch operation or Norwood operation will have 2 ml of blood drawn prior to cardiac surgery, 2 ml blood drawn each day after cardiac surgery as long as the patient remains in the intensive care unit with indwelling lines (maximum of 5 days) and 2 ml blood drawn on the day of the followup brain magnetic resonance imaging study (if not within the maximum of 5 days) to determine blood concentrations S100B and NSE.
- Brain magnetic resonance imaging (MRI) including T1, 2, DWI, spectroscopy, and magnetic resonance angiography, will be performed prior to cardiac surgery and following cardiac surgery in all study patients. Timing of the follow-up brain magnetic resonance imaging including T1, 2, DWI, spectroscopy, and magnetic resonance angiography, will be based on stability of the patient as assessed by the attending physician. Optimal timing for brain magnetic resonance imaging is 4 days postop.
- Maternal information including level of education, medications, and medical history will be obtained. Two mls of blood will also be obtained from the mother to determine maternal blood concentrations of S100B and NSE.
- Study patient clinical variables, including vital signs (heart rate, blood pressure, respiratory rate), systemic oxygen saturation by extremity pulse oximetry, near infrared spectroscopy (NIRS), routine laboratory values will be obtained at the time of each study blood sample.
- Operative variables including cardiopulmonary bypass time, aortic cross clamp time, circulatory arrest time, and hematocrit on bypass will be obtained. Transfusion quantity of packed red blood cells, fresh frozen plasma, platelets, and cryoprecipitate used in the operating room and in the cardiac intensive care unit will also be obtained
- Outcome variables including length of mechanical ventilation, hospital stay, and gross neurological abnormalities (clinical seizures) will be obtained. Follow-up:
- All patients will have neurodevelopmental testing at 6 months after heart surgery.
- Another 2 mls of blood S100B and NSE will be obtained when the patient returns at 6 months for neurodevelopmental testing.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| newborn cardiac surgical study group | – | – |
Who may qualify
- Ages
- 1 day to 30 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Ten consecutive full-term (>36 week gestation) neonates, one day to 30 days of age, presenting for cardiac surgery for arterial switch operation or Norwood operation will be eligible for the study
Key inclusion criteria (3 listed)
- Ten consecutive full-term (>36 week gestation) neonates, one day to 30 days of age, presenting for cardiac surgery for arterial switch operation or Norwood operation will be eligible for the study.
- No patient will be excluded because of race or ethnicity.
- Parental or legal guardian consent will be obtained for all patients prior to enrollment.
Key exclusion criteria (5 listed)
- Newborns with multiple organ abnormalities in addition to their heart defect such as diaphragmatic hernia, tracheo-esophageal fistula, and congenital syndromes involving multiple organs will be excluded from participation.
- Newborns with genetic syndromes associated with developmental delay will also be excluded.
- Newborns with birth asphyxia, 5 minute Apgar score < 5, will be excluded. Patients with multiple organ failure, syndromes, and birth asphyxia have other causes for neurodevelopmental abnormalities.
- Those patients unable to return for postop follow-up and neurodevelopmental testing will be excluded from participation.
- Those patients with parents/guardians who are unable to read or speak English will be excluded from participation.
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
Diagnose brain ischemia in infants using a biomarker blood test.
Time frame: 6 months
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 27 Nov 2013.
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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.
Janet M Simsic, MD principal investigator
Emory University
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 Congenital Disorders, run by Emory 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 3 inclusion and 5 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 27 Nov 2013. 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?
Diagnose brain ischemia in infants using a biomarker blood test. (time frame: 6 months). 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 27 Nov 2013; AzTrials last refreshed its copy on 7 Nov 2026.