IRT in Infants With Intestinal Perforation
The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2013 by Children's Hospitals and Clinics of Minnesota.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Children's Hospitals and Clinics of Minnesota
Information provided by (Responsible Party):
Nicole Birge, Children's Hospitals and Clinics of Minnesota
ClinicalTrials.gov Identifier:
NCT01530828
First received: February 8, 2012
Last updated: August 7, 2013
Last verified: August 2013
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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 |
|---|
|
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 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Determine if factors other than intestinal perforation affect serum IRT. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
| 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) |
| 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 (Child) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Probability Sample |
Study Population
Premature infants less than 1000 grams, age 1-16 days
Criteria
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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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01530828
Please refer to this study by its ClinicalTrials.gov identifier: NCT01530828
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 | |
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 |
| ClinicalTrials.gov Identifier: | NCT01530828 History of Changes |
| Other Study ID Numbers: | SPOT IRT |
| Study First Received: | February 8, 2012 |
| Last Updated: | August 7, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by 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 |
ClinicalTrials.gov processed this record on September 23, 2016