IRT in Infants With Intestinal Perforation
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ClinicalTrials.gov Identifier: NCT01530828 |
Recruitment Status
: Unknown
Verified August 2013 by Nicole Birge, Children's Hospitals and Clinics of Minnesota.
Recruitment status was: Recruiting
First Posted
: February 10, 2012
Last Update Posted
: August 9, 2013
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Condition or disease |
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Intestinal Perforation Necrotizing Enterocolitis |
Study Type : | Observational |
Estimated Enrollment : | 300 participants |
Observational Model: | Case-Only |
Time Perspective: | Prospective |
Official Title: | Immunoreactive Trypsinogen in Infants With Intestinal Perforation |
Study Start Date : | August 2010 |
Estimated Primary Completion Date : | September 2013 |
Estimated Study Completion Date : | August 2014 |
Group/Cohort |
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Premature infants
Weight less than 1000 grams, age 1 - 16 days.
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- To determine the onset and duration of elevation in serum IRT in infants with intestinal perforation. [ Time Frame: 3 years ]
- Determine if factors other than intestinal perforation affect serum IRT. [ Time Frame: 3 years ]

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Ages Eligible for Study: | up to 16 Days (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Probability Sample |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 pat.meyers@childrensmn.org | |
Sub-Investigator: Mark Bergeron, MD |
Responsible Party: | Nicole Birge, Prinicpal Investigator, Children's Hospitals and Clinics of Minnesota |
ClinicalTrials.gov Identifier: | NCT01530828 History of Changes |
Other Study ID Numbers: |
SPOT IRT |
First Posted: | February 10, 2012 Key Record Dates |
Last Update Posted: | August 9, 2013 |
Last Verified: | August 2013 |
Keywords provided by Nicole Birge, Children's Hospitals and Clinics of Minnesota:
Immunoreactive Trypsinogen Nectrotizing Enterocolitis Premature Infants Serial IRT |
Additional relevant MeSH terms:
Enterocolitis Enterocolitis, Necrotizing Intestinal Perforation Gastroenteritis |
Gastrointestinal Diseases Digestive System Diseases Intestinal Diseases |