NCT00332592

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2006

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 31, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 1, 2006

Completed
4 months until next milestone

Study Start

First participant enrolled

October 1, 2006

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
Last Updated

July 22, 2011

Status Verified

May 1, 2008

Enrollment Period

3.3 years

First QC Date

May 31, 2006

Last Update Submit

July 20, 2011

Conditions

Necrotizing Enterocolitis

Keywords

Necrotizing EnterocolitisIntragastric microdialysisPeritoneal microdialysisInfants

Eligibility Criteria

Age3 Days - 6 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Premature children with NEC

You may qualify if:

  • Neonates who are hospitalized because of suspicion of NEC.
  • Neonates who has surgery because of NEC.

You may not qualify if:

  • Non-acceptance from the child's parents or custody holder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Surgical department A, Odense University Hospital

Odense, 5000, Denmark

Location

Related Publications (1)

  • 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.

    PMID: 21292087DERIVED

MeSH Terms

Conditions

Enterocolitis, Necrotizing

Condition Hierarchy (Ancestors)

EnterocolitisGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Study Officials

  • Niels Qvist, Professor

    Odense University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 31, 2006

First Posted

June 1, 2006

Study Start

October 1, 2006

Primary Completion

January 1, 2010

Study Completion

May 1, 2010

Last Updated

July 22, 2011

Record last verified: 2008-05

Locations

DK(1)