IRT in Infants With Intestinal Perforation

NCT01530828 | Unknown

• 1 other identifier: SPOT IRT
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Intestinal Perforation; Necrotizing Enterocolitis

Keywords

Immunoreactive Trypsinogen; Nectrotizing Enterocolitis; Premature Infants; Serial IRT

Outcome Measures

Primary Outcomes (1)

• To determine the onset and duration of elevation in serum IRT in infants with intestinal perforation.

  3 years

Secondary Outcomes (1)

• Determine if factors other than intestinal perforation affect serum IRT.

  3 years

Study Arms (1)

Premature infants

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

Eligibility Criteria

• Age: 1 Day - 16 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Premature infants less than 1000 grams, age 1-16 days

You may qualify if:

• Informed consent
• Birth weight less than 1000 grams
• Admitted to investigative site within first 16 days of life.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Children's Hospitals and Clinics of Minnesota: lead

Study Sites (1)

Children's Hospitals & Clinics of Minnesota

Saint Paul, Minnesota, 55102, United States

RECRUITING

MeSH Terms

Conditions

Intestinal Perforation; Enterocolitis, Necrotizing; Premature Birth

Condition Hierarchy (Ancestors)

Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Enterocolitis; Gastroenteritis; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prinicpal Investigator

Study Record Dates

• First Submitted: February 8, 2012
• First Posted: February 10, 2012
• Study Start: August 1, 2010
• Primary Completion: September 1, 2013
• Study Completion: August 1, 2014
• Last Updated: August 9, 2013

Record last verified: 2013-08

Locations

US (1)