IRT in Infants With Intestinal Perforation

August 7, 2013 updated by: Nicole Birge, Children's Hospitals and Clinics of Minnesota

Immunoreactive Trypsinogen in Infants With Intestinal Perforation

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.

Study Overview

Status

Unknown

Conditions

Detailed Description

At least 300 infants age 1-16 days will be enrolled. IRT values will be obtained daily through day of life 21, if the infant is already having labs drawn that day. The primary outcomes will be intestinal perforation and/or death on or before day of life 21. Each patient will be followed until death or discharge. Discharge will be defined as the release of the infant to home. Infants who are transferred to another NICU may be followed if the receiving NICU is one of the investigational sites. Transfer includes the release of the infant to outside units or other units within the same hospital. The purpose of this follow up is to obtain serial IRT values through day of life 21.

Study Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • St. Paul, Minnesota, United States, 55102
        • Recruiting
        • Children's Hospitals & Clinics of Minnesota
        • Contact:
        • Sub-Investigator:
          • Mark Bergeron, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 2 weeks (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Premature infants less than 1000 grams, age 1-16 days

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Premature infants
Weight less than 1000 grams, age 1 - 16 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To determine the onset and duration of elevation in serum IRT in infants with intestinal perforation.
Time Frame: 3 years
3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Determine if factors other than intestinal perforation affect serum IRT.
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Hospitals and Clinics of Minnesota

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2010

Primary Completion (Anticipated)

September 1, 2013

Study Completion (Anticipated)

August 1, 2014

Study Registration Dates

First Submitted

February 8, 2012

First Submitted That Met QC Criteria

February 9, 2012

First Posted (Estimate)

February 10, 2012

Study Record Updates

Last Update Posted (Estimate)

August 9, 2013

Last Update Submitted That Met QC Criteria

August 7, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SPOT IRT

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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