Ignite Creation Date:
2024-05-05 @ 4:53 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00332592
Status:
COMPLETED
Last Update Posted:
2011-07-22
First Post:
2006-05-31
Brief Title:
Intragastric and Peritoneal Microdialysis in Infants With Necrotizing Enterocolitis NEC
Sponsor:
Odense University Hospital
Organization:
Odense University Hospital
Study Overview
Official Title:
Intragastric and Intraperitoneal Microdialysis in Infants With NEC
Status:
COMPLETED
Status Verified Date:
2008-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None