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IRT in Infants With Intestinal Perforation

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2013 by Children's Hospitals and Clinics of Minnesota.
Recruitment status was:  Recruiting
Information provided by (Responsible Party):
Nicole Birge, Children's Hospitals and Clinics of Minnesota Identifier:
First received: February 8, 2012
Last updated: August 7, 2013
Last verified: August 2013
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.

Intestinal Perforation
Necrotizing Enterocolitis

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Immunoreactive Trypsinogen in Infants With Intestinal Perforation

Resource links provided by NLM:

Further study details as provided by Children's Hospitals and Clinics of Minnesota:

Primary Outcome Measures:
  • To determine the onset and duration of elevation in serum IRT in infants with intestinal perforation. [ Time Frame: 3 years ]

Secondary Outcome Measures:
  • Determine if factors other than intestinal perforation affect serum IRT. [ Time Frame: 3 years ]

Estimated Enrollment: 300
Study Start Date: August 2010
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Premature infants
Weight less than 1000 grams, age 1 - 16 days.

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.

Ages Eligible for Study:   up to 16 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Premature infants less than 1000 grams, age 1-16 days

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01530828

United States, Minnesota
Children's Hospitals & Clinics of Minnesota Recruiting
St. Paul, Minnesota, United States, 55102
Contact: Pat A Meyers, BS    651-220-6026   
Sub-Investigator: Mark Bergeron, MD         
Sponsors and Collaborators
Children's Hospitals and Clinics of Minnesota
  More Information

Responsible Party: Nicole Birge, Prinicpal Investigator, Children's Hospitals and Clinics of Minnesota Identifier: NCT01530828     History of Changes
Other Study ID Numbers: SPOT IRT
Study First Received: February 8, 2012
Last Updated: August 7, 2013

Keywords provided by Children's Hospitals and Clinics of Minnesota:
Immunoreactive Trypsinogen
Nectrotizing Enterocolitis
Premature Infants
Serial IRT

Additional relevant MeSH terms:
Enterocolitis, Necrotizing
Intestinal Perforation
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases processed this record on April 28, 2017