NEC Thermography Infrared Imaging Study

NCT03994341 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 12

Last updated 2020-11-30

No results posted yet for this study

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

Interventions

DIAGNOSTIC_TEST

A FLIR Thermovision a320M thermal IR camera

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.

Sponsors & Collaborators

  • Carleton University

    collaborator OTHER
  • Ottawa Hospital Research Institute

    lead OTHER

Principal Investigators

  • Erika Bariciak, Dr. · CHEO and The Ottawa Hospital

Eligibility

Min Age
26 Weeks
Max Age
42 Weeks
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-08-13
Primary Completion
2020-02-01
Completion
2020-04-02

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03994341 on ClinicalTrials.gov