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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
Sponsor:
Information provided by (Responsible Party):
Nicole Birge, Children's Hospitals and Clinics of Minnesota

Brief Summary:
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 or disease
Intestinal Perforation Necrotizing Enterocolitis

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.

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

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort
Premature infants
Weight less than 1000 grams, age 1 - 16 days.



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

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


Information from the National Library of Medicine

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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
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.

Information from the National Library of Medicine

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


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

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