IRT in Infants With Intestinal Perforation

Status unconfirmed

Conditions studied: Intestinal Perforation, Necrotizing Enterocolitis

In brief

This study is designed to evaluate a novel tool to aid in the diagnosis of intestinal perforation in infants who are at high risk. Analysis of perforation rates of all infants in the three largest participating sites shows that the majority of infants with perforation will do so prior to day of life 21. This study will target the group of infants at highest risk for IP, those with birth weight less than 1000 grams, within the time frame most likely to capture the perforation. Hypothesis: An IRT value exists that can adequately differentiate premature infants with and without intestinal perforation in the first 3 weeks of life.

Key facts

Study ID

NCT01530828

Run by

Children's Hospitals and Clinics of Minnesota

People needed

300

Starts

2010-08-01

Expected to finish

2014-08-01

Last updated by the study team

2013-08-09

Who can join

Age: 0 and older, up to 0. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Informed consent
• Birth weight less than 1000 grams
• Admitted to investigative site within first 16 days of life.

You may not qualify if…

• Evidence of Intestinal perforation in utero
• Suspected or confirmed custic fibrosis
• Abdominal wall defect or intestinal atresia
• Concomitant medical condition that may create an unacceptable risk.

Where it is running

• Children's Hospitals & Clinics of Minnesota — Saint Paul, Minnesota, United States (enrolling)

Full record on ClinicalTrials.gov

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