Intragastric and Peritoneal Microdialysis in Infants With Necrotizing Enterocolitis (NEC)
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Intragastric and Intraperitoneal Microdialysis in Infants With NEC|
|Study Start Date:||October 2006|
|Study Completion Date:||May 2010|
|Primary Completion Date:||January 2010 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00332592
|Surgical department A, Odense University Hospital|
|Odense, Denmark, 5000|
|Principal Investigator:||Niels Qvist, Professor||Odense University Hospital|