Necrotizing EnterocolitisNCT03994341
NEC Thermography Infrared Imaging Study
An observational study of Necrotizing Enterocolitis, run by Ottawa Hospital Research Institute at 2 sites in Canada.
Trial summary
Necrotizing enterocolitis (NEC) is a devastating disease affecting the intestines of premature infants. It involves intestine swelling, tissue destruction, infection, and even death. Read more about this study
- Who is it for?
- Ages 26 to 42 weeksHealthy volunteers can take part
- Conditions the study is for
- Necrotizing Enterocolitis
- What is being tested?
- A FLIR Thermovision a320M thermal IR camera
- How many people
- 12 participants
- Where
- 2 sitesCanada
- Study dates
- 13 Aug 2019to 2 Apr 2020
- 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 26 to 42 weeks
- All sexes
- Healthy volunteers accepted
- Child
Study population: Neonates admitted to the NICU at CHEO or TOH-GC
Who may be able to join
- NEC Group:
- Babies who are 26+0 - 42+0 weeks corrected gestational age and are admitted to the CHEO or TOH-GC NICU.
- Diagnosed with definitive, minimum Bell's stage 2 necrotizing enterocolitis
- In stable condition (with respect to respiratory status, heart rate, blood pressure, oxygen saturation and pain control) as determined by the study physician.
- Normal Group:
- Babies born at 26+0 - 42+0 weeks gestation who are admitted to the CHEO or TOH-GC NICU.
- No clinical or radiological, signs commonly associated with necrotizing enterocolitis, no diagnosis of clinical sepsis or hypotension.
- In stable condition (with respect to respiratory status, heart rate, blood pressure, oxygen saturation and pain control) as determined by the study physician.
Who cannot join
- Any baby with a known congenital anomaly involving the intra-abdominal organs or abdominal wall.
- Any baby with umbilical lines, tapes, or dressings applied to the abdomen that will obscure the thermographic imaging.
- Any baby who has had abdominal surgery within the previous 7 days.
- Any baby deemed to be clinically unstable by the bedside nursing/physician team or the study physician will be excluded from enrollment.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Children's Hospital of Eastern Ontario
Ottawa, Ontario, K1H 8L1
The Ottawa Hospital
Ottawa, Ontario, K1H 8L6
About this study
Official title: Automated Infrared Imaging Tools for Discerning Necrotizing Enterocolitis From Normal Abdominal Thermograms: A Pilot Study
Necrotizing enterocolitis (NEC) is a devastating disease affecting the intestines of premature infants. It involves intestine swelling, tissue destruction, infection, and even death. Improved outcome is highly dependent on early recognition and treatment, however the signs and symptoms of NEC in early stages are not obvious making it difficult to diagnose. Abdominal x-rays and ultrasound can be non-specific and may not show signs of the disease until late in its course.
Infrared imaging is a non-invasive, non-radiation method that can measure the heat given off of the surface of the body and create heat maps. It is being used clinically in other situations but is still under investigation for use in preterm infants with suspected NEC. Computer analysis of the measured heat maps can be used to detect changes in the intestine such as the swelling or tissue destruction involved in NEC.
Our group has previously performed a pilot study that showed that infrared imaging on babies in the NICU can be used to create heat maps that are different between normal babies and those with NEC when analyzed using specialized computer programs. In this study the investigators will improve the imaging process by using special vision sensors to automate the imaging process and make it easier for bedside staff to use this technology. Special programs will be developed to automatically select areas of interest over which temperature maps will be analyzed. The investigators will use this new imaging technique to study a population of newborns diagnosed with definitive NEC and a healthy population of newborns without NEC, and compare the heat maps obtained from each group. From the analysis of the images obtained from these two populations, the investigators will determine the suitability and necessary fine-tuning of this new imaging technique with the hopes that this technology can someday aid in the early diagnosis of NEC.
Read the detailed description
Background information about NEC:
The best prognosis requires early recognition and treatment of NEC. Perforation or ongoing deterioration may require surgical intervention. Mortality has improved in recent years but is still about 15-30 % for non-surgical NEC and up to 50% for surgical NEC. Survivors may suffer significant complications including long-term damage to bowel function.
The initial diagnosis is based on clinical exam and diagnostic imaging, usually involving abdominal x-rays +/- ultrasound. Bell's staging criteria incorporates clinical, laboratory, and radiographic findings, and is used to discern suspected NEC from definitive NEC. Bell's stage 2 denotes proven NEC and involves the presence of pneumatosis intestinalis and/or portal venous gas on x-ray.
The main difficulty when diagnosing NEC is that early/suspected stages of NEC present clinically and radiographically in a similar way to benign feeding intolerance seen with prematurity. Abdominal x-rays involve exposure of the patient to ionizing radiation and ultrasound imaging is disruptive to the patient, takes time to perform, and requires skilled operators who have limited availability. These modalities will only show non-specific changes in early stages of NEC. Late findings are more discerning, however by the time these findings are apparent the optimal time frame to initiate treatment is often missed.
Background Information About Medical Thermography:
Medical infrared (IR) imaging is a combination of medical technology, infrared camera technology and computer multimedia technology. Infrared imaging devices record the human thermal fields. The human body is a natural biological heating source and an infrared thermal imager converts the far-infrared light wave radiated by the human body to an electrical signal which is then converted into a digital quantity by analog/digital conversion. The signals are processed by multimedia image processing technology into a color heat map, showing the body's temperature field. A normal, healthy body has a characteristic heat map while an abnormal body exhibits deviations from this heat map. Thus, comparing the similarities and differences between the two, in combination with clinical diagnosis, doctors and researchers can infer the nature and extent of a disease.
The investigators investigated various methods of computerized assessment of thermal images obtained from premature babies with definitive NEC compared with normal babies with no symptoms of feeding intolerance. The investigators showed that the discriminating power of the surface temperature evolution data between healthy control babies and those who were diagnosed with NEC was promising, with fairly high classification rate and a simple linear classification scheme. In addition, our results suggested a slower rate of decrease of abdominal skin temperature in the NEC babies, which might be explained by the presence of inflamed bowel. Rice et al. also used medical thermography to help detect NEC in newborn infants admitted to the NICU. By comparing temperature distribution over abdominal segments to those of the chest, they were able to determine differences in normal babies vs those diagnosed with NEC.
Background Information About Medical Microsoft Kinect Sensor:
The Kinect sensor is a widely used, consumer-grade, and safe color and depth camera commercially marketed for use in computer gaming. It measures near infrared light reflected off the body to form a surface map of the environment. The RGB-D Kinect sensor has recently been applied to healthcare in a variety of applications where it has shown to be effective, including the field of medical rehabilitation, where Kinect sensors are used for active exercise training and rehabilitation of patients,for safe and automated radiotherapy delivery, for chest wall motion analysis in cystic fibrosis patients, for facial feature analysis of posture control in rehabilitation patients, in ICU patients for automated mobility measurements, and even automated apnea monitoring in infants and children.
In this study, the RGB-D Kinect sensor's role will essentially consist of supporting the automated segmentation, and retrieval of thermal distribution data from the co-located and calibrated IR FLIR imager. Thanks to the color and depth maps that will be made available, classical and robust image processing techniques will be leveraged to identify regions of interest (the baby's body and eventually abdomen). This sort of precise segmentation cannot be reliably performed solely from IR images, as it is well established that computer vision and image processing techniques are not well adapted for IR images. Early laboratory tests have already been conducted to determine that the operation of the RGB-D sensor in an overlapping field of view with that of the IR imager does not influence the data collected in the heat map. The combined operation is therefore safe and will provide an accurate thermal distribution as if the IR imager was operating alone. The end goal is to combine the strengths of three imaging technologies to improve medical diagnosis.
Study Rationale:
Previous studies investigating thermography and diagnosing NEC only used an infrared camera to acquire images. Although the investigators were able to derive thermal distributions for babies of various GA's, our previous study did not adopt a strict protocol for positioning the IR sensor in an optimal configuration, leading to more variations in image quality and size of region of interest. These limitations made it difficult to automate the selection of accurate regions of interest within the thermal image and required manual intervention from an image processing expert. In our current study the image acquisition process will be improved upon and standardized; a Microsoft Kinect sensor utilizing thermal, color and active depth vision will be integrated into a thermographic camera to allow for automated selection of regions of interest and will facilitate ease of use by medical personal at the patient's bedside. Embedded image processing algorithms will be developed to exploit the multi-spectral nature of collected information in order to automatically segment and unclutter the region of interest over which thermal distributions of relevance will be monitored.
Initial development of this system, including apparatus integration and assembly, rigorous camera calibration procedures in between the RGB-D and IR sensors, and complete testing will be performed in a laboratory environment, using only mock-up models of the clinical environment. Then, in order to fully validate the application of this automated infrared image processing system for early diagnosis of NEC, acquisition of relevant images from human subjects is needed. The study will be pursued in the NICU environment to further validate the newly developed non-invasive and automated imaging protocol on babies of various sizes and GA in the NICU, since NEC can occur in babies ranging from extremely premature to those born at term. Since the investigators hope to use this technology someday to help improve the diagnosis of NEC, the experimental imaging procedure will be performed on two patient populations. The investigators will first image the abdomens of a group of healthy newborns with the newly developed apparatus and image processing protocol to set up a standard thermal distribution. Then, the investigators will also image the abdomens of a group of newborns with proven NEC, using the same equipment. From the analysis of images from these two populations, the investigators will determine the suitability and necessary fine-tuning of the proposed automated infrared imaging tools, with the objective of augmenting the precision, usability, and reliability of the procedure for early diagnosis of NEC.
Objectives:
- Develop an automated approach to the imaging and analysis of preterm infants' abdomens using thermographic sensors and embedded image processing algorithms.
- Derive thermographic temperature distributions of the abdomens of two groups of babies: those who are normal (have no signs of feeding intolerance or signs of NEC), and those who have been diagnosed with proven NEC.
- Determine if the automated image processing algorithms can discern a statistically significant difference between the normal thermal distributions and those derived from babies with NEC.
- Conditions
- Necrotizing Enterocolitis
- Being tested
- A FLIR Thermovision a320M thermal IR camera
- Keywords
- Neonates, Thermography imaging
- Medical subject headings
- Enterocolitis, Necrotizing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A FLIR Thermovision a320M thermal IR cameraDiagnostic test
- Clothing removed if necessary
- ECG leads, temperature probes, or transcutaneous monitors will be relocated for abdominal imaging.
- Axillary temperature prior to starting the thermographic imaging.
- Baby's mattress slid out of the isolette and warming bed will be turned off for no more than 60 seconds. This step is necessary since infrared radiation does not pass through the Plexiglas walls of an isolette and the infant's skin surface needs to cool off slightly.
- After surface cooling, thermal imaging will be recorded for ~60 sec to allow for the infrared radiation naturally emitted by the subject's body to be recorded by the infrared camera. The timestamp corresponding to the removal of the heat source will be noted, to indicate the start of the cooling of the abdomen.
- After ~60 seconds of image recording, the recording will stop, the mattress pushed back into isolette.
- Axillary temperature to ensure temperature stability, any clothes will be put back on.
| Study group | Role | What they receive |
|---|---|---|
| NEC Group | Infrared images of the abdomen, timed at handling. A FLIR Thermovision a320M thermal IR camera bound with an Microsoft Kinect RGB-D sensor system connected to a laptop will be used. Both imaging technologies are non-invasive and represent no risk to the subject. The thermal images record the temperature distribution, the Kinect sensor will acquire color image and depth image that will be used to segment the subject from the background bedding surface. All three sets of images will be collected in synchronization. Thermography requires period of slight cooling of the skin surface to stabilize the body surface temperature. The room temperature will be maintained slightly below thermoneutrality. Thermographic camera will be positioned about 60-70 cm above the baby. Receives: Diagnostic Test: A FLIR Thermovision a320M thermal IR camera | |
| Normal Group | Same procedure for both experimental and active comparator. Receives: Diagnostic Test: A FLIR Thermovision a320M thermal IR camera |
What is being measured
The primary outcome is the main question the study is designed to answer.
Region of interest inclusion
Categorization of heat map as either "complete" or "incomplete" based on the inclusion of the entire abdominal region of interest being captured by our automated thermographic imaging system.
Measured: 2 years
Secondary outcomes (1)
Accurate classification of heat distribution maps as NEC versus Normal
Using machine learning data analysis tools developed in our previous pilot study we will compare the accuracy (sensitivity and specificity and ROC value) of image classifier program to accurately categorize each adbominal thermal image as either Normal or NEC
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 posted21 Jun 2019
- Study start13 Aug 2019
- Primary completion1 Feb 2020
- Study completion2 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Necrotizing EnterocolitisStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Carleton University
- Responsible party
- Sponsor
- Investigators
- Erika Bariciak, Dr., Principal investigator, CHEO and The Ottawa Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03994341
- Sponsor's protocol ID
- NEC-01
- Status last verified
- Nov 2020
- First submitted
- 14 Apr 2019
- Last updated
- 30 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Automated Infrared Imaging Tools for Discerning Necrotizing Enterocolitis From Normal Abdominal Thermograms: A Pilot Study
- ClinicalTrials.gov ID
- NCT03994341
- Acronym / sponsor ID
- NEC-01
- Conditions
- Necrotizing Enterocolitis
- Keywords
- Neonates, Thermography imaging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Collaborators
- Carleton University
- Study start
- 13 Aug 2019 (actual)
- Primary completion
- 1 Feb 2020 (actual)
- Study completion
- 2 Apr 2020 (actual)
- First posted
- 21 Jun 2019 (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.
Necrotizing enterocolitis (NEC) is a devastating disease affecting the intestines of premature infants. It involves intestine swelling, tissue destruction, infection, and even death. Improved outcome is highly dependent on early recognition and treatment, however the signs and symptoms of NEC in early stages are not obvious making it difficult to diagnose. Abdominal x-rays and ultrasound can be non-specific and may not show signs of the disease until late in its course.
Infrared imaging is a non-invasive, non-radiation method that can measure the heat given off of the surface of the body and create heat maps. It is being used clinically in other situations but is still under investigation for use in preterm infants with suspected NEC. Computer analysis of the measured heat maps can be used to detect changes in the intestine such as the swelling or tissue destruction involved in NEC.
Our group has previously performed a pilot study that showed that infrared imaging on babies in the NICU can be used to create heat maps that are different between normal babies and those with NEC when analyzed using specialized computer programs. In this study the investigators will improve the imaging process by using special vision sensors to automate the imaging process and make it easier for bedside staff to use this technology. Special programs will be developed to automatically select areas of interest over which temperature maps will be analyzed. The investigators will use this new imaging technique to study a population of newborns diagnosed with definitive NEC and a healthy population of newborns without NEC, and compare the heat maps obtained from each group. From the analysis of the images obtained from these two populations, the investigators will determine the suitability and necessary fine-tuning of this new imaging technique with the hopes that this technology can someday aid in the early diagnosis of NEC.
Detailed description
Background information about NEC:
The best prognosis requires early recognition and treatment of NEC. Perforation or ongoing deterioration may require surgical intervention. Mortality has improved in recent years but is still about 15-30 % for non-surgical NEC and up to 50% for surgical NEC. Survivors may suffer significant complications including long-term damage to bowel function.
The initial diagnosis is based on clinical exam and diagnostic imaging, usually involving abdominal x-rays +/- ultrasound. Bell's staging criteria incorporates clinical, laboratory, and radiographic findings, and is used to discern suspected NEC from definitive NEC. Bell's stage 2 denotes proven NEC and involves the presence of pneumatosis intestinalis and/or portal venous gas on x-ray.
The main difficulty when diagnosing NEC is that early/suspected stages of NEC present clinically and radiographically in a similar way to benign feeding intolerance seen with prematurity. Abdominal x-rays involve exposure of the patient to ionizing radiation and ultrasound imaging is disruptive to the patient, takes time to perform, and requires skilled operators who have limited availability. These modalities will only show non-specific changes in early stages of NEC. Late findings are more discerning, however by the time these findings are apparent the optimal time frame to initiate treatment is often missed.
Background Information About Medical Thermography:
Medical infrared (IR) imaging is a combination of medical technology, infrared camera technology and computer multimedia technology. Infrared imaging devices record the human thermal fields. The human body is a natural biological heating source and an infrared thermal imager converts the far-infrared light wave radiated by the human body to an electrical signal which is then converted into a digital quantity by analog/digital conversion. The signals are processed by multimedia image processing technology into a color heat map, showing the body's temperature field. A normal, healthy body has a characteristic heat map while an abnormal body exhibits deviations from this heat map. Thus, comparing the similarities and differences between the two, in combination with clinical diagnosis, doctors and researchers can infer the nature and extent of a disease.
The investigators investigated various methods of computerized assessment of thermal images obtained from premature babies with definitive NEC compared with normal babies with no symptoms of feeding intolerance. The investigators showed that the discriminating power of the surface temperature evolution data between healthy control babies and those who were diagnosed with NEC was promising, with fairly high classification rate and a simple linear classification scheme. In addition, our results suggested a slower rate of decrease of abdominal skin temperature in the NEC babies, which might be explained by the presence of inflamed bowel. Rice et al. also used medical thermography to help detect NEC in newborn infants admitted to the NICU. By comparing temperature distribution over abdominal segments to those of the chest, they were able to determine differences in normal babies vs those diagnosed with NEC.
Background Information About Medical Microsoft Kinect Sensor:
The Kinect sensor is a widely used, consumer-grade, and safe color and depth camera commercially marketed for use in computer gaming. It measures near infrared light reflected off the body to form a surface map of the environment. The RGB-D Kinect sensor has recently been applied to healthcare in a variety of applications where it has shown to be effective, including the field of medical rehabilitation, where Kinect sensors are used for active exercise training and rehabilitation of patients,for safe and automated radiotherapy delivery, for chest wall motion analysis in cystic fibrosis patients, for facial feature analysis of posture control in rehabilitation patients, in ICU patients for automated mobility measurements, and even automated apnea monitoring in infants and children.
In this study, the RGB-D Kinect sensor's role will essentially consist of supporting the automated segmentation, and retrieval of thermal distribution data from the co-located and calibrated IR FLIR imager. Thanks to the color and depth maps that will be made available, classical and robust image processing techniques will be leveraged to identify regions of interest (the baby's body and eventually abdomen). This sort of precise segmentation cannot be reliably performed solely from IR images, as it is well established that computer vision and image processing techniques are not well adapted for IR images. Early laboratory tests have already been conducted to determine that the operation of the RGB-D sensor in an overlapping field of view with that of the IR imager does not influence the data collected in the heat map. The combined operation is therefore safe and will provide an accurate thermal distribution as if the IR imager was operating alone. The end goal is to combine the strengths of three imaging technologies to improve medical diagnosis.
Study Rationale:
Previous studies investigating thermography and diagnosing NEC only used an infrared camera to acquire images. Although the investigators were able to derive thermal distributions for babies of various GA's, our previous study did not adopt a strict protocol for positioning the IR sensor in an optimal configuration, leading to more variations in image quality and size of region of interest. These limitations made it difficult to automate the selection of accurate regions of interest within the thermal image and required manual intervention from an image processing expert. In our current study the image acquisition process will be improved upon and standardized; a Microsoft Kinect sensor utilizing thermal, color and active depth vision will be integrated into a thermographic camera to allow for automated selection of regions of interest and will facilitate ease of use by medical personal at the patient's bedside. Embedded image processing algorithms will be developed to exploit the multi-spectral nature of collected information in order to automatically segment and unclutter the region of interest over which thermal distributions of relevance will be monitored.
Initial development of this system, including apparatus integration and assembly, rigorous camera calibration procedures in between the RGB-D and IR sensors, and complete testing will be performed in a laboratory environment, using only mock-up models of the clinical environment. Then, in order to fully validate the application of this automated infrared image processing system for early diagnosis of NEC, acquisition of relevant images from human subjects is needed. The study will be pursued in the NICU environment to further validate the newly developed non-invasive and automated imaging protocol on babies of various sizes and GA in the NICU, since NEC can occur in babies ranging from extremely premature to those born at term. Since the investigators hope to use this technology someday to help improve the diagnosis of NEC, the experimental imaging procedure will be performed on two patient populations. The investigators will first image the abdomens of a group of healthy newborns with the newly developed apparatus and image processing protocol to set up a standard thermal distribution. Then, the investigators will also image the abdomens of a group of newborns with proven NEC, using the same equipment. From the analysis of images from these two populations, the investigators will determine the suitability and necessary fine-tuning of the proposed automated infrared imaging tools, with the objective of augmenting the precision, usability, and reliability of the procedure for early diagnosis of NEC.
Objectives:
- Develop an automated approach to the imaging and analysis of preterm infants' abdomens using thermographic sensors and embedded image processing algorithms.
- Derive thermographic temperature distributions of the abdomens of two groups of babies: those who are normal (have no signs of feeding intolerance or signs of NEC), and those who have been diagnosed with proven NEC.
- Determine if the automated image processing algorithms can discern a statistically significant difference between the normal thermal distributions and those derived from babies with NEC.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NEC Group | – | Diagnostic Test: A FLIR Thermovision a320M thermal IR cameraInfrared images of the abdomen, timed at handling. A FLIR Thermovision a320M thermal IR camera bound with an Microsoft Kinect RGB-D sensor system connected to a laptop will be used. Both imaging technologies are non-invasive and represent no risk to the subject. The thermal images record the temperature distribution, the Kinect sensor will acquire color image and depth image that will be used to segment the subject from the background bedding surface. All three sets of images will be collected in synchronization. Thermography requires period of slight cooling of the skin surface to stabilize the body surface temperature. The room temperature will be maintained slightly below thermoneutrality. Thermographic camera will be positioned about 60-70 cm above the baby. |
| Normal Group | – | Diagnostic Test: A FLIR Thermovision a320M thermal IR cameraSame procedure for both experimental and active comparator. |
Who may qualify
- Ages
- 26 to 42 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Neonates admitted to the NICU at CHEO or TOH-GC
Key inclusion criteria (8 listed)
- Babies who are 26+0 - 42+0 weeks corrected gestational age and are admitted to the CHEO or TOH-GC NICU.
- Diagnosed with definitive, minimum Bell's stage 2 necrotizing enterocolitis
- In stable condition (with respect to respiratory status, heart rate, blood pressure, oxygen saturation and pain control) as determined by the study physician.
- Babies born at 26+0 - 42+0 weeks gestation who are admitted to the CHEO or TOH-GC NICU.
- No clinical or radiological, signs commonly associated with necrotizing enterocolitis, no diagnosis of clinical sepsis or hypotension.
Key exclusion criteria (4 listed)
- Any baby with a known congenital anomaly involving the intra-abdominal organs or abdominal wall.
- Any baby with umbilical lines, tapes, or dressings applied to the abdomen that will obscure the thermographic imaging.
- Any baby who has had abdominal surgery within the previous 7 days.
- Any baby deemed to be clinically unstable by the bedside nursing/physician team or the study physician will be excluded from enrollment.
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 |
|---|---|---|
| A FLIR Thermovision a320M thermal IR camera1. Clothing removed if necessary 2. ECG leads, temperature probes, or transcutaneous monitors will be relocated for abdominal imaging. 3. Axillary temperature prior to starting the thermographic imaging. 4. Baby's mattress slid out of the isolette and warming bed will be turned off for no more than 60 seconds. This step is necessary since infrared radiation does not pass through the Plexiglas walls of an isolette and the infant's skin surface needs to cool off slightly. 5. After surface cooling, thermal imaging will be recorded for ~60 sec to allow for the infrared radiation naturally emitted by the subject's body to be recorded by the infrared camera. The timestamp corresponding to the removal of the heat source will be noted, to indicate the start of the cooling of the abdomen. 6. After ~60 seconds of image recording, the recording will stop, the mattress pushed back into isolette. 7. Axillary temperature to ensure temperature stability, any clothes will be put back on. | Diagnostic test | NEC Group, Normal Group |
Primary outcome
Region of interest inclusion
Time frame: 2 years
Categorization of heat map as either "complete" or "incomplete" based on the inclusion of the entire abdominal region of interest being captured by our automated thermographic imaging system.
1 secondary outcome
Accurate classification of heat distribution maps as NEC versus Normal
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 30 Nov 2020.
- Individual participant dataSharing planned: No
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Necrotizing Enterocolitis
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.
Erika Bariciak, Dr. principal investigator
CHEO and The Ottawa Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Necrotizing Enterocolitis, run by Ottawa Hospital Research Institute at 2 sites in Canada.
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 8 inclusion and 4 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 30 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. 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?
Region of interest inclusion (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 30 Nov 2020.