StrokeNIRSCINCT02950181
Descriptive Analysis of Near Infrared Spectroscopy in Critically Ill and Injured Pediatric and Neonatal Patients
A study testing NIRS in people with Stroke and Diabetic Ketoacidosis, run by Arkansas Children's Hospital Research Institute at 1 site in United States.
Trial summary
This study involves looking at Cerebral oximetry measurements in pediatric and neonatal patients who are experiencing a critical illness. Such as Altered mental status, seizures, trauma, sepsis, etc. Read more about this study
- Who is it for?
- Ages 1 day to 21 years
- Conditions the study is for
- Stroke, Diabetic Ketoacidosis, Increased Intracranial Pressures
- What is being tested?
- NIRS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 299 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jul 2014to 1 Jan 2019
- Phase
- Interventional
- 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 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Trauma: non-accidental trauma, Level One or Two Trauma with altered mental status, traumatic brain injury, altered mental status with trauma history, vascular compromise
- Or medical: possible strokes, diabetic ketoacidosis, increased intracranial pressure, altered mental status, sepsis, drowning, shock, rapid sequence intubations, seizures, altered mental status, strokes, possible shunt malfunctions
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
United States1 site
Arkansas Children's Hospital
Little Rock, Arkansas, 72202
About this study
This study involves looking at Cerebral oximetry measurements in pediatric and neonatal patients who are experiencing a critical illness. Such as Altered mental status, seizures, trauma, sepsis, etc.
Read the detailed description
At Arkansas Children's Hospital (ACH) Pediatric Emergency Department (PED), NIRS cerebral tissue oxygenation rSO2 monitoring has become an adjunct noninvasive monitoring assessment tool along with Pulse Oximetry and End-Tidal CO2 in the critically ill and injured neonatal and pediatric patients' resuscitation endeavors or management. This has become a standard monitoring tool for patients who require medical (possible strokes, diabetic ketoacidosis, increased intracranial pressure, altered mental status, sepsis, drowning, shock, rapid sequence intubations, seizures, altered mental status, strokes, possible shunt malfunctions) or trauma (non-accidental trauma, Level One or Two Trauma with altered mental status, traumatic brain injury, altered mental status with trauma history, vascular compromise) resuscitation efforts.
Data will be collected as a retrospective and prospective chart review from the electronic medical record of patients that were treated in the pediatric emergency department of Arkansas Children's Hospital from 10-1-13 who require medical (possible strokes, diabetic ketoacidosis, increased intracranial pressure, altered mental status, sepsis, drowning, shock, rapid sequence intubations, seizures, altered mental status, strokes, possible shunt malfunctions) or trauma (non-accidental trauma, Level One or Two Trauma with altered mental status, traumatic brain injury, altered mental status with trauma history, vascular compromise) resuscitation efforts. This study will be based on the patient information recorded in these records, such as age, medications delivered, vital signs, interventions and outcomes and compared to their PED NIRS cerebral tissue oxygenation rSO2 data. All study subject materials will be assigned a unique identifying code or number. The cerebral NIRS rSO2 data will be collected/graphed and de-identified.
- Being tested
- NIRS
- Medical subject headings
- Stroke, Diabetic Ketoacidosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NIRSDevice
Correlating the NIRS/Cerebral Oximetry readings to the various critical ill and injured pediatric patients, trends, interventions, and outcomes
| Study group | Role | What they receive |
|---|---|---|
| Specific Aim | Experimental | Correlating the NIRS/Cerebral Oximetry readings to the various critical ill and injured pediatric patients, trends, interventions, and outcomes Receives: Device: NIRS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Observing Cerebral oximetry readings when patients present to the pediatric emergency department
All study data will be obtained from the physical or electronic medical records obtained at Arkansas Children's Hospital. Patient's NIRS and vital signs data will be in an excel format with de-identified patient information which will be age, interventions, and etiology as denoted as Medical vs. Trauma (see study population for inclusion criteria). This is a data review with de-identified patient chart analysis for age, weight, past medical histories, co-morbidities, medical or surgical interventions, medications, seizures, duration of events, cardiac arrest, respiratory failure, intubations, and outcomes. All relevant information will be entered into a Redcap database. All study subject materials will be assigned a unique identifying code or number.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2016 (estimated)
- Study start29 Jul 2014
- Primary completion1 Jan 2019
- Study completion1 Jan 2019
Why it stopped: Concerns over standard of care and recruiting process. Investigator left UAMS, therefore study halted immediately
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 299 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arkansas Children's Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02950181
- Sponsor's protocol ID
- 202674
- Acronym
- NIRSCI
- Status last verified
- May 2020
- First submitted
- 19 Oct 2016
- Last updated
- 28 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Descriptive Analysis of Near Infrared Spectroscopy in Critically Ill and Injured Pediatric and Neonatal Patients
- ClinicalTrials.gov ID
- NCT02950181
- Acronym / sponsor ID
- NIRSCI / 202674
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Concerns over standard of care and recruiting process. Investigator left UAMS, therefore study halted immediately
- Enrolment
- 299 participants (actual)
- Lead sponsor
- Arkansas Children's Hospital Research InstituteUniversity, hospital or other
- Study start
- 29 Jul 2014 (actual)
- Primary completion
- 1 Jan 2019 (actual)
- Study completion
- 1 Jan 2019 (actual)
- First posted
- 1 Nov 2016 (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.
This study involves looking at Cerebral oximetry measurements in pediatric and neonatal patients who are experiencing a critical illness. Such as Altered mental status, seizures, trauma, sepsis, etc.
Detailed description
At Arkansas Children's Hospital (ACH) Pediatric Emergency Department (PED), NIRS cerebral tissue oxygenation rSO2 monitoring has become an adjunct noninvasive monitoring assessment tool along with Pulse Oximetry and End-Tidal CO2 in the critically ill and injured neonatal and pediatric patients' resuscitation endeavors or management. This has become a standard monitoring tool for patients who require medical (possible strokes, diabetic ketoacidosis, increased intracranial pressure, altered mental status, sepsis, drowning, shock, rapid sequence intubations, seizures, altered mental status, strokes, possible shunt malfunctions) or trauma (non-accidental trauma, Level One or Two Trauma with altered mental status, traumatic brain injury, altered mental status with trauma history, vascular compromise) resuscitation efforts.
Data will be collected as a retrospective and prospective chart review from the electronic medical record of patients that were treated in the pediatric emergency department of Arkansas Children's Hospital from 10-1-13 who require medical (possible strokes, diabetic ketoacidosis, increased intracranial pressure, altered mental status, sepsis, drowning, shock, rapid sequence intubations, seizures, altered mental status, strokes, possible shunt malfunctions) or trauma (non-accidental trauma, Level One or Two Trauma with altered mental status, traumatic brain injury, altered mental status with trauma history, vascular compromise) resuscitation efforts. This study will be based on the patient information recorded in these records, such as age, medications delivered, vital signs, interventions and outcomes and compared to their PED NIRS cerebral tissue oxygenation rSO2 data. All study subject materials will be assigned a unique identifying code or number. The cerebral NIRS rSO2 data will be collected/graphed and de-identified.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Specific Aim | Experimental | Device: NIRSCorrelating the NIRS/Cerebral Oximetry readings to the various critical ill and injured pediatric patients, trends, interventions, and outcomes |
Who may qualify
- Ages
- 1 day to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Trauma: non-accidental trauma, Level One or Two Trauma with altered mental status, traumatic brain injury, altered mental status with trauma history, vascular compromise
- Or medical: possible strokes, diabetic ketoacidosis, increased intracranial pressure, altered mental status, sepsis, drowning, shock, rapid sequence intubations, seizures, altered mental status, strokes, possible shunt malfunctions
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| NIRSCorrelating the NIRS/Cerebral Oximetry readings to the various critical ill and injured pediatric patients, trends, interventions, and outcomes | Device | Specific Aim |
Primary outcome
Observing Cerebral oximetry readings when patients present to the pediatric emergency department
Time frame: 4 years
All study data will be obtained from the physical or electronic medical records obtained at Arkansas Children's Hospital. Patient's NIRS and vital signs data will be in an excel format with de-identified patient information which will be age, interventions, and etiology as denoted as Medical vs. Trauma (see study population for inclusion criteria). This is a data review with de-identified patient chart analysis for age, weight, past medical histories, co-morbidities, medical or surgical interventions, medications, seizures, duration of events, cardiac arrest, respiratory failure, intubations, and outcomes. All relevant information will be entered into a Redcap database. All study subject materials will be assigned a unique identifying code or number.
Results and safety
The study was stopped early (reason given: Concerns over standard of care and recruiting process. Investigator left UAMS, therefore study halted immediately). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2020.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NIRS in people with Stroke and Diabetic Ketoacidosis, run by Arkansas Children's Hospital Research Institute 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 2 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: stopped early, as of the sponsor's last update on 28 May 2020. 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 was stopped early (reason given: Concerns over standard of care and recruiting process. Investigator left UAMS, therefore study halted immediately). Results are not available in the source record.
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?
Observing Cerebral oximetry readings when patients present to the pediatric emergency department (time frame: 4 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 28 May 2020.