NEC Thermography Infrared Imaging Study

NCT03994341 | Completed

• 1 other identifier: NEC-01
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Necrotizing Enterocolitis

Keywords

Neonates; Thermography imaging

Outcome Measures

Primary Outcomes (1)

• 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.

  2 years

Secondary Outcomes (1)

• Accurate classification of heat distribution maps as NEC versus Normal

  2 years

Study Arms (2)

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.

Diagnostic Test: A FLIR Thermovision a320M thermal IR camera

Normal Group

Same procedure for both experimental and active comparator.

Diagnostic Test: A FLIR Thermovision a320M thermal IR camera

Interventions

A FLIR Thermovision a320M thermal IR camera DIAGNOSTIC_TEST

1. 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.

NEC Group; Normal Group

Eligibility Criteria

• Age: 26 Weeks - 42 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Neonates admitted to the NICU at CHEO or TOH-GC

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead
• Carleton University: collaborator

Study Sites (2)

Children's Hospital of Eastern Ontario

Ottawa, Ontario, K1H 8L1, Canada

Location

The Ottawa Hospital

Ottawa, Ontario, K1H 8L6, Canada

Location

MeSH Terms

Conditions

Enterocolitis, Necrotizing

Condition Hierarchy (Ancestors)

Enterocolitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Erika Bariciak, Dr.

  CHEO and The Ottawa Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2019
• First Posted: June 21, 2019
• Study Start: August 13, 2019
• Primary Completion: February 1, 2020
• Study Completion: April 2, 2020
• Last Updated: November 30, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)