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IRT in Infants With Intestinal Perforation

NCT01530828 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 300

Last updated 2013-08-09

No results posted yet for this study

Summary

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.

Conditions

  • Intestinal Perforation
  • Necrotizing Enterocolitis

Sponsors & Collaborators

  • Children's Hospitals and Clinics of Minnesota

    lead OTHER

Eligibility

Min Age
1 Day
Max Age
16 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-08-31
Primary Completion
2013-09-30
Completion
2014-08-31

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 NCT01530828 on ClinicalTrials.gov