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

NCT ID: NCT00332592

Last Updated: 2011-07-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

14 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-10-31

Study Completion Date

2010-05-31

Brief Summary

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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

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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.

Conditions

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Necrotizing Enterocolitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

3 Days

Maximum Eligible Age

6 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Odense University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Surgical department A, Odense University Hospital

Principal Investigators

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Niels Qvist, Professor

Role: PRINCIPAL_INVESTIGATOR

Odense University Hospital

Locations

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Surgical department A, Odense University Hospital

Odense, , Denmark

Site Status

Countries

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Denmark

References

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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. doi: 10.1016/j.jpedsurg.2010.11.015.

Reference Type DERIVED
PMID: 21292087 (View on PubMed)

Other Identifiers

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VF-20060037

Identifier Type: -

Identifier Source: org_study_id

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