- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01287559
Monitoring Necrotizing Enterocolitis in Premature Infants
Monitoring Necrotizing Enterocolitis in Premature Infants Using Depth-Resolved Broad Spectrum NIRS
Study Overview
Status
Conditions
Detailed Description
In this 5-year study, we extend our prior feasibility study to test the hypothesis that very-low-birth-weight neonates (VLBW) who develop necrotizing enterocolitis (NEC) can be reliably detected early in the process using broadband optical spectroscopy sensitive to changes in perfusion of the gut. Such perfusion changes result in regional tissue hypoxemia, which we have demonstrated to be detectable by combined broadband visible/near-infrared tissue oximetry, a real-time method that can assess the adequacy of deep tissue oxygenation. Initially this will be an optical-only device; then combining it with ultrasound will be studied in years 2-5, first on the benchtop, and then in the intensive care unit.
Necrotizing enterocolitis (NEC) is the most common life-threatening surgical emergency encountered in the neonatal intensive care unit [ ]. NEC is a multi-factorial (infectious, inflammatory, and ischemic) disease of the gastrointestinal (GI) tract of newborns and neonates. The end result is mucosal injury and/or transmural necrosis of the intestine. Currently, there is no test to diagnose NEC in the early stages of the disease, before the later and ominous clinical signs appear. The mortality of NEC ranges from 10% to 50%, approaching 100% for neonates with severe forms of the disease characterized by full-thickness necrosis of the intestine, followed by rupture and sepsis.
Ninety percent of NEC cases occur in infants born before 36 weeks' gestational age, occurring in up to 10% of all very-low-birth-weight (VLBW, <1500g) neonates [ ]. A diagnosis of NEC increases the NICU length of stay by 22-60 days, and increases the total hospital charges by $76,000-$186,000 per case [ ]. Finally, Neonates recovering from NEC often incur additional serious complications (malnutrition, liver dysfunction). NEC requiring surgery carries increased risk of cerebral palsy, cognitive or psychomotor impairment, or both.
Repeated attempts to use clinical signs to reliably identify neonates most likely to progress to severe NEC have been unsuccessful. Broadband oximetry appears to offer a solution. Developed by the PI and others, broadband oximetry is sensitive to ischemia. It differs from typical near-infrared spectroscopy (NIRS) methods that generally use only 2-4 wavelengths in that broadband oximetry measures hundreds of wavelengths. Broadband approaches, have shown significantly tighter normal ranges, lower noise, and better reproducibility in vivo. Further, typical NIRS fails to account for shifts in water, fat, blood volume, and stool, any of which can affect oxygenation measurements if not specifically accounted for, making NIRS unreliable for quantitative studies of the gut. In contrast, in our just-completed 1-year feasibility R43 trial, we demonstrated that NEC can be detected using broadband methods. The question remains: how will this new device perform clinically in a multicenter study? By incorporating broadband oximetry monitoring into the management of VLBW neonates, we may detect NEC at its earliest stages and prevent the cascade that leads to bowel necrosis. Success should lead quickly to clinical use, as this team has previously developed, received FDA approval for, and commercialized two biomedical devices.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: David Benaron Benaron, MD
- Phone Number: 1236 6508514040
- Email: dbenaron@spectros.com
Study Contact Backup
- Name: John Bagnatori
- Phone Number: 1224 6508514040
- Email: dbenaron@spectros.com
Study Locations
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California
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Irvine, California, United States, 92602
- University of California, Irvine
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Texas
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Dallas, Texas, United States, 75201
- University of Texas
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Neonates weighing 500-1,500 g on admission
- Neonates eligible for full care and resuscitation as necessary (no parental request for D.N.R.)
- Enrollment within 12h of suspected NEC; scanning within 24h of diagnosis (unless matched control)
- Informed consent
Exclusion Criteria:
- Refusal or withdrawal of consent
- Skin or mucosal integrity disorders, beyond prematurity (e.g. epidermolysis bullosa, herpes simplex)
- Major congenital malformations and gastrointestinal tract malformation precluding initiations of feeds(e.g., congenital obstruction of GI tract, gastroschisis, omphalocele)
- critically ill neonates, who are unlikely to survive
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Subjects with NEC
Infants in which a possible diagnosis of NEC is suspected
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Control Infants
Age-matched and illness-severity matched to NEC subjects, controls are infants NOT suspected of having NEC.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Diagnosis of NEC by Optical vs. Standard Clinical
Time Frame: 2 weeks
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Diagnosis of NEC by Optical vs. Standard Clinical will be compared, to see if optical facilitates an early diagnosis
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2 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time frame of ischemia associated with NEC: Early vs Late
Time Frame: 2 weeks
|
Ischemia may be an early or late feature of NEC.
If early, it can serve for early diagnosis.
If late, it will help with late diagnosis, but not be useful early in the course of disease.
There is no clear evidence as to which of these is true.
|
2 weeks
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NEO-005
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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