332592
Last Update Posted: 2011-07-22
Recruiting has ended
All Genders accepted | 3 Days-6 months |
14 Estimated Participants | No Expanded Access |
Observational Study | Does not accept healthy volunteers |
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.
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.
Eligibility
Relevant conditions:
Necrotizing Enterocolitis
If you aren't sure if you meet the criteria above speak to your healthcare professional. Criteria may be updated but not reflected here, do not hesitate to contact the trial if you think are close to fitting criteria.
locations
Data sourced from ClinicalTrials.gov