Monitoring Necrotizing Enterocolitis in Premature Infants
Status unconfirmed
Conditions studied: Necrotizing Enterocolitis
In brief
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.
Key facts
- Study ID
- NCT01287559
- Run by
- Spectros Corporation
- People needed
- 100
- Starts
- 2011-03-01
- Last updated by the study team
- 2011-02-01
Who can join
Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- University of California, Irvine — Irvine, California, United States
- University of Texas — Dallas, Texas, United States
Full record on ClinicalTrials.gov
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