IRT in Infants With Intestinal Perforation

Study Description

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 Design

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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

Groups and Cohorts

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

Outcome Measures

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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 ]

Eligibility Criteria

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Contacts and Locations

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations 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
First Posted:	February 10, 2012
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