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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. Identifier: NCT00332592
Recruitment Status : Completed
First Posted : June 1, 2006
Last Update Posted : July 22, 2011
Information provided by:
Odense University Hospital

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.

Condition or disease
Necrotizing Enterocolitis

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.

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Study Type : Observational
Actual Enrollment : 14 participants
Observational Model: Cohort
Time Perspective: Prospective
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

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Information from the National Library of Medicine

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Ages Eligible for Study:   up to 6 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Premature children with NEC

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT00332592

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Surgical department A, Odense University Hospital
Odense, Denmark, 5000
Sponsors and Collaborators
Odense University Hospital
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Principal Investigator: Niels Qvist, Professor Odense University Hospital

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Niels Qvist, Surgical department A, Odense University Hospital Identifier: NCT00332592     History of Changes
Other Study ID Numbers: VF-20060037
First Posted: June 1, 2006    Key Record Dates
Last Update Posted: July 22, 2011
Last Verified: May 2008
Keywords provided by Odense University Hospital:
Necrotizing Enterocolitis
Intragastric microdialysis
Peritoneal microdialysis
Additional relevant MeSH terms:
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Enterocolitis, Necrotizing
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases