Exposed to AnesthesiaNCT01229514
Functional Magnetic Resonance Imaging (fMRI) Findings in Children With Early Exposure to General Anesthesia
An observational study of Exposed to Anesthesia, run by Nationwide Children's Hospital at 1 site in United States.
Trial summary
General anesthetic medications have been shown to cause neuronal cell death in the brains of infant rodents. Ethanol and general anesthetics both act on NMDA and GABA receptors,and appear to have similar mechanisms of toxicity in the immature rodent brain. Read more about this study
- Who is it for?
- Ages 10 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Exposed to Anesthesia
- What is being tested?
- fMRI
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2008to Jun 2011
- 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 10 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children from Nationwide Children's Hospital
Who may be able to join
- Children ages 10-17 years with an history of exposure to general anesthesia for at least one hour in duration during the ages of 0-24 months of age.
- The cognitive ability to complete fMRI imaging.
- Consent of the subject's guardians and assent of the subject.
- Right hand dominance.
- English language speaker.
Who cannot join
- Subjects with known possibility or knowledge of pregnancy.
- Documentation of hemodynamic or respiratory instability documented on the anesthetic record
- Subjects with the inability to complete MRI imaging without sedation.
- History of prenatal ethanol exposure.
- History of exposure to antiepileptic medication.
- History of Attention Deficit Disorder (ADD), or Attention Deficit Hyperactivity Disorder (ADHD)
Show all 9Show fewer
- History of traumatic brain injury
- History of psychiatric disease or exposure to psychoactive medications.
- History of substance abuse.
Trial locations and contacts
1 site in 1 country.
United States1 site
Nationwide Children's Hospital
Columbus, Ohio, 43205
About this study
Official title: A Comparison of Functional Magnetic Resonance Imaging (fMRI) Findings in Children With and Without a History of Early Exposure to General Anesthetics
General anesthetic medications have been shown to cause neuronal cell death in the brains of infant rodents. Ethanol and general anesthetics both act on NMDA and GABA receptors,and appear to have similar mechanisms of toxicity in the immature rodent brain. Functional MRI (fMRI) is a technique developed for mapping brain activation and has been utilized to examine how the brains of children with a history of early exposure to ethanol function differently from children without such a history. This study will utilize fMRI to look for specific changes in brain activation patterns in children with a history of early exposure to general anesthesia, as compared to children without such exposure.
- Conditions
- Exposed to Anesthesia
- Being tested
- fMRI
- Keywords
- Children, before, the age of 2 years
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fMRIOther
fMRI and a response inhibition task to examine activation patterns in the prefrontal cortex and caudate nucleus
| Study group | Role | What they receive |
|---|---|---|
| Exposure to anesthesia | Not described Receives: Other: fMRI | |
| Normal controls | Not described Receives: Other: fMRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Use of fMRI as a tool
To evaluate the use of fMRI as a tool to investigate the functional consequence of exposure to general anesthetic medications during early brain development
Measured: one time 10 to 17 yrs. post-anesthesia
Secondary outcomes (1)
Brain activation patterns
To compare brain activation patterns in children with and without a history of early exposure to general anesthetic medications while peforming a specific task (go/no-go).
Measured: one time 10 to 17 yrs. post-anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2010 (estimated)
- Study startOct 2008
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Exposed to AnesthesiaStudies of the same condition, open and under way.
- More trials run by Nationwide Children's HospitalThe 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nationwide Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas Taghon, Nationwide Children's Hospital
- Investigators
- Thomas Taghon, DO, Principal investigator, Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01229514
- Sponsor's protocol ID
- IRB07-00456
- Status last verified
- Jun 2012
- First submitted
- 26 Oct 2010
- Last updated
- 2 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Jevtovic-Todorovic V, Hartman RE, Izumi Y, Benshoff ND, Dikranian K, Zorumski CF, Olney JW, Wozniak DF. Early exposure to common anesthetic agents causes widespread neurodegeneration in the developing rat brain and persistent learning deficits. J Neurosci. 2003 Feb 1;23(3):876-82. doi: 10.1523/JNEUROSCI.23-03-00876.2003.
PubMed 12574416Mellon RD, Simone AF, Rappaport BA. Use of anesthetic agents in neonates and young children. Anesth Analg. 2007 Mar;104(3):509-20. doi: 10.1213/01.ane.0000255729.96438.b0.
PubMed 17312200
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Functional Magnetic Resonance Imaging (fMRI) Findings in Children With and Without a History of Early Exposure to General Anesthetics
- ClinicalTrials.gov ID
- NCT01229514
- Acronym / sponsor ID
- IRB07-00456
- Conditions
- Exposed to Anesthesia
- Keywords
- Children, before, the age of 2 years
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Nationwide Children's HospitalUniversity, hospital or other
- Study start
- Oct 2008
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 27 Oct 2010 (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.
General anesthetic medications have been shown to cause neuronal cell death in the brains of infant rodents. Ethanol and general anesthetics both act on NMDA and GABA receptors,and appear to have similar mechanisms of toxicity in the immature rodent brain. Functional MRI (fMRI) is a technique developed for mapping brain activation and has been utilized to examine how the brains of children with a history of early exposure to ethanol function differently from children without such a history. This study will utilize fMRI to look for specific changes in brain activation patterns in children with a history of early exposure to general anesthesia, as compared to children without such exposure.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exposure to anesthesia | – | Other: fMRI |
| Normal controls | – | Other: fMRI |
Who may qualify
- Ages
- 10 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children from Nationwide Children's Hospital
Key inclusion criteria (5 listed)
- Children ages 10-17 years with an history of exposure to general anesthesia for at least one hour in duration during the ages of 0-24 months of age.
- The cognitive ability to complete fMRI imaging.
- Consent of the subject's guardians and assent of the subject.
- Right hand dominance.
- English language speaker.
Key exclusion criteria (9 listed)
- Subjects with known possibility or knowledge of pregnancy.
- Documentation of hemodynamic or respiratory instability documented on the anesthetic record
- Subjects with the inability to complete MRI imaging without sedation.
- History of prenatal ethanol exposure.
- History of exposure to antiepileptic medication.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fMRIfMRI and a response inhibition task to examine activation patterns in the prefrontal cortex and caudate nucleus | Other | Exposure to anesthesia, Normal controls |
Primary outcome
Use of fMRI as a tool
Time frame: one time 10 to 17 yrs. post-anesthesia
To evaluate the use of fMRI as a tool to investigate the functional consequence of exposure to general anesthetic medications during early brain development
1 secondary outcome
Brain activation patterns
Time frame: one time 10 to 17 yrs. post-anesthesia
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 2 Aug 2012.
- Background: PubMed 12574416Jevtovic-Todorovic V, Hartman RE, Izumi Y, Benshoff ND, Dikranian K, Zorumski CF, Olney JW, Wozniak DF. Early exposure to common anesthetic agents causes widespread neurodegeneration in the developing rat brain and persistent learning deficits. J Neurosci. 2003 Feb 1;23(3):876-82. doi: 10.1523/JNEUROSCI.23-03-00876.2003.
- Background: PubMed 17312200Mellon RD, Simone AF, Rappaport BA. Use of anesthetic agents in neonates and young children. Anesth Analg. 2007 Mar;104(3):509-20. doi: 10.1213/01.ane.0000255729.96438.b0.
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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.
Thomas Taghon, DO principal investigator
Nationwide Children's Hospital
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 Exposed to Anesthesia, run by Nationwide Children's Hospital 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 5 inclusion and 9 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 2 Aug 2012. 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?
Use of fMRI as a tool (time frame: one time 10 to 17 yrs. post-anesthesia). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01229514, which also lists 2 linked publications.
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 2 Aug 2012.