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

This study has been completed.
Sponsor:
Information provided by:
Odense University Hospital
ClinicalTrials.gov Identifier:
NCT00332592
First received: May 31, 2006
Last updated: July 20, 2011
Last verified: May 2008
History of Changes

May 31, 2006
July 20, 2011
October 2006
January 2010   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00332592 on ClinicalTrials.gov Archive Site
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Intragastric and Peritoneal Microdialysis in Infants With Necrotizing Enterocolitis (NEC)
Intragastric and Intraperitoneal Microdialysis in Infants With 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.
Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

Premature children with NEC
Necrotizing Enterocolitis
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Pedersen ME, Dahl M, Qvist N. Intraperitoneal microdialysis in the postoperative surveillance after surgery for necrotizing enterocolitis: a preliminary report. J Pediatr Surg. 2011 Feb;46(2):352-6.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
14
May 2010
January 2010   (final data collection date for primary outcome measure)

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
Both
up to 6 Months
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT00332592
VF-20060037
No
Niels Qvist, Surgical department A, Odense University Hospital
Odense University Hospital
Not Provided
Principal Investigator: Niels Qvist, Professor Odense University Hospital
Odense University Hospital
May 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP