Monitoring Necrotizing Enterocolitis in Premature Infants

NCT01287559 | Unknown DMC

• 1 other identifier: NEO-005
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

NEC; Premature Infant

Outcome Measures

Primary Outcomes (1)

• Diagnosis of NEC by Optical vs. Standard Clinical

  Diagnosis of NEC by Optical vs. Standard Clinical will be compared, to see if optical facilitates an early diagnosis

  2 weeks

Secondary Outcomes (1)

• Time frame of ischemia associated with NEC: Early vs Late

  2 weeks

Study Arms (2)

Subjects with NEC

Infants in which a possible diagnosis of NEC is suspected

Control Infants

Age-matched and illness-severity matched to NEC subjects, controls are infants NOT suspected of having NEC.

Eligibility Criteria

• Age: Up to 6 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Infants hospitalized for prematurity in a Neonatal ICU

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

Sponsors & Collaborators

• Spectros Corporation: lead
• University of California: collaborator
• University of Texas: collaborator

Study Sites (2)

University of California, Irvine

Irvine, California, 92602, United States

Location

University of Texas

Dallas, Texas, 75201, United States

Location

MeSH Terms

Conditions

Enterocolitis, Necrotizing; Premature Birth

Condition Hierarchy (Ancestors)

Enterocolitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• David Benaron, MD

  Spectros Corporation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David Benaron Benaron, MD

CONTACT

6508514040; dbenaron@spectros.com

John Bagnatori

CONTACT

6508514040; dbenaron@spectros.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 30, 2011
• First Posted: February 1, 2011
• Study Start: March 1, 2011
• Primary Completion: December 1, 2011
• Last Updated: February 1, 2011

Record last verified: 2011-01

Locations

US (2)