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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00332592
Other study ID # VF-20060037
Secondary ID
Status Completed
Phase Phase 4
First received May 31, 2006
Last updated July 20, 2011
Start date October 2006
Est. completion date May 2010

Study information

Verified date May 2008
Source Odense University Hospital
Contact n/a
Is FDA regulated No
Health authority Denmark: Ethics Committee
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 14
Est. completion date May 2010
Est. primary completion date January 2010
Accepts healthy volunteers No
Gender Both
Age group N/A to 6 Months
Eligibility 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Locations

Country Name City State
Denmark Surgical department A, Odense University Hospital Odense

Sponsors (1)

Lead Sponsor Collaborator
Odense University Hospital

Country where clinical trial is conducted

Denmark, 

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