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Monitoring Necrotizing Enterocolitis in Premature Infants

NCT01287559 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2011-02-01

No results posted yet for this study

Summary

The investigators are studying a disease called "necrotizing enterocolitis" (or "NEC" for short), which affects premature infants. It is the most common surgical emergency involving neonates admitted to Newborn Intensive Care Units. Currently, clinicians are unable to identify which infants will go on to develop NEC before they become ill. Clinical signs of illness occur relatively late in the course of the condition, making NEC more difficult to treat. The investigators will test a new probe that uses safe levels of visible and infrared light, with and without ultrasound imaging, to see if the investigators can identify infants before they get sick using a simple, noninvasive test, This test will be repeated through at least one feeding (which stresses the gut) each day. If successful, the health benefit will be large, as it is estimated that treating NEC alone (not including treating its later complications) adds $650 million to the annual health bill.

Conditions

  • Necrotizing Enterocolitis

Sponsors & Collaborators

  • University of California

    collaborator OTHER

  • University of Texas

    collaborator OTHER

  • Spectros Corporation

    lead INDUSTRY

Principal Investigators

  • David Benaron, MD · Spectros Corporation

Eligibility

Max Age
6 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-03-31
Primary Completion
2011-12-31

Countries

  • United States

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 NCT01287559 on ClinicalTrials.gov