IRT in Infants With Intestinal Perforation
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Purpose
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.
| Condition |
|---|
|
Necrotizing Enterocolitis With Pneumatosis and Perforation |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | Immunoreactive Trypsinogen in Infants With Intestinal Perforation |
| Estimated Enrollment: | 300 |
| Study Start Date: | August 2010 |
| Estimated Study Completion Date: | August 2012 |
| Estimated Primary Completion Date: | August 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
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.
Eligibility| Ages Eligible for Study: | up to 16 Days |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Probability Sample |
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| 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 | |
More Information
No publications provided
| 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 |
| Study First Received: | February 8, 2012 |
| Last Updated: | February 9, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Children's Hospitals and Clinics of Minnesota:
|
Immunoreactive Trypsinogen Intestinal Perforation Nectrotizing Enterocolitis Premature Infants Serial IRT |
Additional relevant MeSH terms:
|
Enterocolitis Intestinal Perforation Enterocolitis, Necrotizing Gastroenteritis |
Gastrointestinal Diseases Digestive System Diseases Intestinal Diseases |
ClinicalTrials.gov processed this record on May 23, 2013