Necrotizing Enterocolitis Clinical Trial
Official title:
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.
Status | Recruiting |
Enrollment | 300 |
Est. completion date | August 2014 |
Est. primary completion date | September 2013 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | N/A to 16 Days |
Eligibility |
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. |
Observational Model: Case-Only, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
United States | Children's Hospitals & Clinics of Minnesota | St. Paul | Minnesota |
Lead Sponsor | Collaborator |
---|---|
Children's Hospitals and Clinics of Minnesota |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To determine the onset and duration of elevation in serum IRT in infants with intestinal perforation. | 3 years | No | |
Secondary | Determine if factors other than intestinal perforation affect serum IRT. | 3 years | No |
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