IRT in Infants With Intestinal Perforation

Necrotizing Enterocolitis Clinical Trial

Official title:

Immunoreactive Trypsinogen in Infants With Intestinal Perforation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01530828
• Other study ID #: SPOT IRT
• Status: Recruiting
• Phase: N/A
• First received: February 8, 2012
• Last updated: August 7, 2013
• Start date: August 2010
• Est. completion date: August 2014

Study information

• Verified date: August 2013
• Source: Children's Hospitals and Clinics of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: August 2014
• Est. primary completion date: September 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 16 Days

Eligibility

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.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Enterocolitis
• Enterocolitis, Necrotizing
• Intestinal Perforation
• Necrotizing Enterocolitis

Locations

Country	Name	City	State
United States	Children's Hospitals & Clinics of Minnesota	St. Paul	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospitals and Clinics of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the onset and duration of elevation in serum IRT in infants with intestinal perforation.		3 years	No
Secondary	Determine if factors other than intestinal perforation affect serum IRT.		3 years	No