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
  Purpose

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 Phase
Necrotizing Enterocolitis
Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Intragastric and Intraperitoneal Microdialysis in Infants With NEC

Resource links provided by NLM:


Further study details as provided by Odense University Hospital:

Enrollment: 14
Study Start Date: October 2006
Study Completion Date: May 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   up to 6 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Premature children with NEC

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00332592

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

No publications provided by Odense University Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Niels Qvist, Surgical department A, Odense University Hospital
ClinicalTrials.gov Identifier: NCT00332592     History of Changes
Other Study ID Numbers: VF-20060037
Study First Received: May 31, 2006
Last Updated: July 20, 2011
Health Authority: Denmark: Ethics Committee

Keywords provided by Odense University Hospital:
Necrotizing Enterocolitis
Intragastric microdialysis
Peritoneal microdialysis
Infants

Additional relevant MeSH terms:
Enterocolitis
Enterocolitis, Necrotizing
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on August 28, 2014