IRT in Infants With Intestinal Perforation

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by Children's Hospitals and Clinics of Minnesota
Sponsor:
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
  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
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. 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

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

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: 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
Intestinal Perforation
Enterocolitis, Necrotizing
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on August 28, 2014