SeizuresNCT03561168
Review of Diagnostic Yield of MRI Brain Results in Children Under Age 3 Years
An observational study of Seizures and Development Delay, run by Baylor College of Medicine at 1 site in United States.
Trial summary
The investigators aim to identify the frequency with which an elective brain MRI yields and etiologic diagnosis to explain its indication. The protocol includes children undergoing elective brain MRI with anesthesia prior to their third birthday. Read more about this study
- Who is it for?
- Ages Up to 1095 days
- Conditions the study is for
- Seizures, Development Delay, Anesthetic Neurotoxicity
- What is being tested?
- Change in plan of care based on MRI results
- How many people
- 561 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Oct 2017to 15 Jun 2018
- 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 Up to 1095 days
- All sexes
- No healthy volunteers
- Child
Study population: Children under age 3 undergoing MRI brain with anesthesia or sedation between Dec 13, 2015 and Dec 13, 2016
Who may be able to join
- Male or female aged 0-36 months who received anesthesia (volatile gas anesthesia) or IV sedation (propofol, dexmedetomidine, barbiturates, benzodiazepines, or other agents) for brain MRI
Who cannot join
- MRI without sedation, brain MRI plus additional MRI imaging, i.e. spine, heart, etc., sedated MRI by a member of other department besides Anesthesiology.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Retrospective Review of Indications and Results of Brain MRI With Anesthesia/Sedation in Children Less Than Three Years of Age
The investigators aim to identify the frequency with which an elective brain MRI yields and etiologic diagnosis to explain its indication. The protocol includes children undergoing elective brain MRI with anesthesia prior to their third birthday.
Read the detailed description
On December 14, 2016 the FDA issued a warning regarding elective anesthetics in children under three years of age. While a single, short exposure to general anesthesia may not have negative effects on behavior or learning, repeated or prolonged anesthetics may affect brain development. To that end, minimizing exposure to elective general anesthetics if procedures are not clearly indicated in young children appeals to reason.
- Conditions
- Seizures, Development Delay, Anesthetic Neurotoxicity
- Being tested
- Change in plan of care based on MRI results
- Keywords
- Pediatric, MRI Indications, Anesthesia, Anesthetic Neurotoxicity, MRI Diagnostic Yield
- Medical subject headings
- Seizures, Learning Disabilities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Change in plan of care based on MRI resultsDiagnostic test
Study subjects have "received the intervention" if the results of their MRI either 1. provide an etiology for said MRI's indication or 2. the patient received a change in plan of care based on MRI results.
| Study group | Role | What they receive |
|---|---|---|
| Developmental Delay | Children under age 3 who underwent MRI brain with anesthesia for the indication of Developmental Delay (between the dates of Dec 13, 2015 - Dec 13, 2016) at our institution. Receives: Diagnostic Test: Change in plan of care based on MRI results | |
| Seizure | Children under age 3 who underwent MRI brain with anesthesia for the indication of Seizure (between the dates of Dec 13, 2015 - Dec 13, 2016) at our institution. Receives: Diagnostic Test: Change in plan of care based on MRI results | |
| Developmental Delay and Seizure | Children under age 3 who underwent MRI brain with anesthesia for the indication of Developmental Delay and Seizure (between the dates of Dec 13, 2015 - Dec 13, 2016) at our institution. Receives: Diagnostic Test: Change in plan of care based on MRI results |
What is being measured
The primary outcome is the main question the study is designed to answer.
Etiologic diagnosis obtained from MRI brain
Determine the incidence of brain MRI abnormality that led to etiological explanation of developmental delay, autism or seizure.
Measured: 1 year
Secondary outcomes (2)
Quantify anesthetic exposure
To determine the doses of all anesthetic and sedative agents administered and the duration of anesthesia
Measured: 1 year
Incidence of repeat MRI
To determine the incidence of repeat MRI scan in the study population. anesthesia. To determine the incidence of repeat MRI scan in the study population.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2018
- Study start12 Oct 2017
- Primary completion15 Jun 2018
- Study completion15 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for SeizuresStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe 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
- Retrospective
- Enrolment
- 561 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jamie Sinton, Baylor College of Medicine
- Investigators
- Dean B Andropoulos, MD, Study director, Baylor College of MedicineJamie W Sinton, MD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03561168
- Sponsor's protocol ID
- H-41288
- Status last verified
- Jun 2018
- First submitted
- 7 Jun 2018
- Last updated
- 19 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: This is a retrospective study, this question seems not applicable.
Publications
Murias K, Moir A, Myers KA, Liu I, Wei XC. Systematic review of MRI findings in children with developmental delay or cognitive impairment. Brain Dev. 2017 Sep;39(8):644-655. doi: 10.1016/j.braindev.2017.04.006. Epub 2017 Apr 27.
PubMed 28457518Simpson GA, Colpe L, Greenspan S. Measuring functional developmental delay in infants and young children: prevalence rates from the NHIS-D. Paediatr Perinat Epidemiol. 2003 Jan;17(1):68-80. doi: 10.1046/j.1365-3016.2003.00459.x.
PubMed 12562474Rodriguez DP, Poussaint TY. Neuroimaging of the child with developmental delay. Top Magn Reson Imaging. 2007 Feb;18(1):75-92. doi: 10.1097/RMR.0b013e3180f63511.
PubMed 17607144Decobert F, Grabar S, Merzoug V, Kalifa G, Ponsot G, Adamsbaum C, des Portes V. Unexplained mental retardation: is brain MRI useful? Pediatr Radiol. 2005 Jun;35(6):587-96. doi: 10.1007/s00247-005-1406-x. Epub 2005 Mar 1.
PubMed 15739114Schaefer GB, Bodensteiner JB. Radiological findings in developmental delay. Semin Pediatr Neurol. 1998 Mar;5(1):33-8. doi: 10.1016/s1071-9091(98)80016-8.
PubMed 9548639Huang YY, Li L, Monteleone M, Ferrari L, States LJ, Riviello JJ, Kernie SG, Mencin AA, Gupta S, Sun LS. Use of Anesthesia for Imaging Studies and Interventional Procedures in Children. J Neurosurg Anesthesiol. 2016 Oct;28(4):400-404. doi: 10.1097/ANA.0000000000000355.
PubMed 27564559
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Review of Indications and Results of Brain MRI With Anesthesia/Sedation in Children Less Than Three Years of Age
- ClinicalTrials.gov ID
- NCT03561168
- Acronym / sponsor ID
- H-41288
- Conditions
- Seizures, Development Delay, Anesthetic Neurotoxicity
- Keywords
- Pediatric, MRI Indications, Anesthesia, Anesthetic Neurotoxicity, MRI Diagnostic Yield
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 561 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Study start
- 12 Oct 2017 (actual)
- Primary completion
- 15 Jun 2018 (actual)
- Study completion
- 15 Jun 2018 (actual)
- First posted
- 19 Jun 2018 (actual)
- 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 aim to identify the frequency with which an elective brain MRI yields and etiologic diagnosis to explain its indication. The protocol includes children undergoing elective brain MRI with anesthesia prior to their third birthday.
Detailed description
On December 14, 2016 the FDA issued a warning regarding elective anesthetics in children under three years of age. While a single, short exposure to general anesthesia may not have negative effects on behavior or learning, repeated or prolonged anesthetics may affect brain development. To that end, minimizing exposure to elective general anesthetics if procedures are not clearly indicated in young children appeals to reason.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Developmental Delay | – | Diagnostic Test: Change in plan of care based on MRI resultsChildren under age 3 who underwent MRI brain with anesthesia for the indication of Developmental Delay (between the dates of Dec 13, 2015 - Dec 13, 2016) at our institution. |
| Seizure | – | Diagnostic Test: Change in plan of care based on MRI resultsChildren under age 3 who underwent MRI brain with anesthesia for the indication of Seizure (between the dates of Dec 13, 2015 - Dec 13, 2016) at our institution. |
| Developmental Delay and Seizure | – | Diagnostic Test: Change in plan of care based on MRI resultsChildren under age 3 who underwent MRI brain with anesthesia for the indication of Developmental Delay and Seizure (between the dates of Dec 13, 2015 - Dec 13, 2016) at our institution. |
Who may qualify
- Ages
- Up to 1095 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children under age 3 undergoing MRI brain with anesthesia or sedation between Dec 13, 2015 and Dec 13, 2016
Key inclusion criteria (1 listed)
- Male or female aged 0-36 months who received anesthesia (volatile gas anesthesia) or IV sedation (propofol, dexmedetomidine, barbiturates, benzodiazepines, or other agents) for brain MRI
Key exclusion criteria (1 listed)
- MRI without sedation, brain MRI plus additional MRI imaging, i.e. spine, heart, etc., sedated MRI by a member of other department besides Anesthesiology.
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 |
|---|---|---|
| Change in plan of care based on MRI resultsStudy subjects have "received the intervention" if the results of their MRI either 1. provide an etiology for said MRI's indication or 2. the patient received a change in plan of care based on MRI results. | Diagnostic test | Developmental Delay, Developmental Delay and Seizure, Seizure |
Primary outcome
Etiologic diagnosis obtained from MRI brain
Time frame: 1 year
Determine the incidence of brain MRI abnormality that led to etiological explanation of developmental delay, autism or seizure.
2 secondary outcomes
Quantify anesthetic exposure
Time frame: 1 year
Incidence of repeat MRI
Time frame: 1 year
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 19 Jun 2018.
- Background: PubMed 28457518Murias K, Moir A, Myers KA, Liu I, Wei XC. Systematic review of MRI findings in children with developmental delay or cognitive impairment. Brain Dev. 2017 Sep;39(8):644-655. doi: 10.1016/j.braindev.2017.04.006. Epub 2017 Apr 27.
- Background: PubMed 12562474Simpson GA, Colpe L, Greenspan S. Measuring functional developmental delay in infants and young children: prevalence rates from the NHIS-D. Paediatr Perinat Epidemiol. 2003 Jan;17(1):68-80. doi: 10.1046/j.1365-3016.2003.00459.x.
- Background: PubMed 17607144Rodriguez DP, Poussaint TY. Neuroimaging of the child with developmental delay. Top Magn Reson Imaging. 2007 Feb;18(1):75-92. doi: 10.1097/RMR.0b013e3180f63511.
- Background: PubMed 15739114Decobert F, Grabar S, Merzoug V, Kalifa G, Ponsot G, Adamsbaum C, des Portes V. Unexplained mental retardation: is brain MRI useful? Pediatr Radiol. 2005 Jun;35(6):587-96. doi: 10.1007/s00247-005-1406-x. Epub 2005 Mar 1.
- Background: PubMed 9548639Schaefer GB, Bodensteiner JB. Radiological findings in developmental delay. Semin Pediatr Neurol. 1998 Mar;5(1):33-8. doi: 10.1016/s1071-9091(98)80016-8.
- Background: PubMed 27564559Huang YY, Li L, Monteleone M, Ferrari L, States LJ, Riviello JJ, Kernie SG, Mencin AA, Gupta S, Sun LS. Use of Anesthesia for Imaging Studies and Interventional Procedures in Children. J Neurosurg Anesthesiol. 2016 Oct;28(4):400-404. doi: 10.1097/ANA.0000000000000355.
- Individual participant dataSharing planned: Undecided. This is a retrospective study, this question seems not applicable.
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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.
Dean B Andropoulos, MD study director
Baylor College of Medicine
Jamie W Sinton, MD principal investigator
Baylor College of Medicine
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 Seizures and Development Delay, run by Baylor College of Medicine 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 19 Jun 2018. 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?
Etiologic diagnosis obtained from MRI brain (time frame: 1 year). 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 NCT03561168, which also lists 6 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 19 Jun 2018.