Intragastric and Peritoneal Microdialysis in Infants With Necrotizing Enterocolitis (NEC)

Necrotizing Enterocolitis Clinical Trial

Official title:

Intragastric and Intraperitoneal Microdialysis in Infants With NEC

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00332592
• Other study ID #: VF-20060037
• Status: Completed
• Phase: Phase 4
• First received: May 31, 2006
• Last updated: July 20, 2011
• Start date: October 2006
• Est. completion date: May 2010

Study information

• Verified date: May 2008
• Source: Odense University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics Committee
• Study type: Observational

Clinical Trial Summary

NEC is a serious inflammatory bowel disease, which almost only strikes infants with low birth weight and low gestational age. The morbidity and mortality rates are high, and early diagnosis and treatment is mandatory. The primary aim of the present study is to investigate the clinical use of intragastric microdialysis and whether it is able to select patients, who may benefit from either medical or surgical therapy. The aim of intraperitoneal microdialysis is to evaluate whether changes in intraperitoneal microdialysis reflect the clinical outcome after laparotomy.

Description:

Neonates who are hospitalized because of suspicion of NEC are subjected to intragastric microdialysis during the observation period. The catheter is placed in the stomach via the naso-oesophageal route. If surgery is necessary a microdialysis catheter is placed in the peritoneal cavity prior to wound closure. Samples are collected every 4-hour. Samples will be analyzed continuously but the results will not be included in the clinical evaluation of the patient.

A total of 20 patients will be included in this pilot study. The results of the intragastric and peritoneal microdialysis will be compared with the clinical course, s-lactate, radiological and pathological findings in each patient.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: May 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 6 Months

Eligibility

Inclusion Criteria:

• Neonates who are hospitalized because of suspicion of NEC.

• Neonates who has surgery because of NEC.

Exclusion Criteria:

• Non-acceptance from the child's parents or custody holder

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Enterocolitis
• Enterocolitis, Necrotizing
• Necrotizing Enterocolitis

Locations

Country	Name	City	State
Denmark	Surgical department A, Odense University Hospital	Odense

Sponsors (1)

Lead Sponsor	Collaborator
Odense University Hospital

Country where clinical trial is conducted

Denmark,