IRT in Infants With Intestinal Perforation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-08-31

Study Completion Date

2014-08-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Intestinal Perforation Necrotizing Enterocolitis

Keywords

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Immunoreactive Trypsinogen Nectrotizing Enterocolitis Premature Infants Serial IRT

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Premature infants

Weight less than 1000 grams, age 1 - 16 days.

No interventions assigned to this group

Eligibility Criteria

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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.

Minimum Eligible Age

1 Day

Maximum Eligible Age

16 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Nicole Birge

Prinicpal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Children's Hospitals & Clinics of Minnesota

Saint Paul, Minnesota, United States

Site Status RECRUITING

Countries

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United States

Facility Contacts

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Pat A Meyers, BS

Role: primary

Other Identifiers

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SPOT IRT

Identifier Type: -

Identifier Source: org_study_id