Intragastric and Peritoneal Microdialysis in Infants With Necrotizing Enterocolitis (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.

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Key information

Conditions

Necrotizing Enterocolitis Digestive System Diseases Enterocolitis Enterocolitis, Necrotizing Gastroenteritis Gastrointestinal Diseases Intestinal Diseases

Age range

3 day–6 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Surgical department A, Odense University Hospital

Odense, 5000, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Sponsors and collaborators

Lead sponsor

Odense University Hospital

Other

Registry information

Official study title

Intragastric and Intraperitoneal Microdialysis in Infants With NEC

Important dates

Study start: 2006
Primary completion: 2010
Study completion: 2010
First posted: Jun 1, 2006
Registry last updated: Jul 22, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed