Intragastric and Peritoneal Microdialysis in Infants With Necrotizing Enterocolitis (NEC)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00332592|
Recruitment Status : Completed
First Posted : June 1, 2006
Last Update Posted : July 22, 2011
|Condition or disease|
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.
|Study Type :||Observational|
|Actual Enrollment :||14 participants|
|Official Title:||Intragastric and Intraperitoneal Microdialysis in Infants With NEC|
|Study Start Date :||October 2006|
|Actual Primary Completion Date :||January 2010|
|Actual Study Completion Date :||May 2010|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00332592
|Surgical department A, Odense University Hospital|
|Odense, Denmark, 5000|
|Principal Investigator:||Niels Qvist, Professor||Odense University Hospital|