- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03869827
Necrotizing Enterocolitis in Fetuses With Intrauterine Growth Restriction (ECUN)
Evaluation of the Risk of Necrotizing Enterocolitis in Fetuses With Intrauterine Growth Restriction.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Muriel DORET, Prof.
- Phone Number: 33 4 27 85 51 70
- Email: muriel.doret-dion@chu-lyon.fr
Study Locations
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-
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Bron, France
- Recruiting
- Hopital Femme Mere Enfant
-
Contact:
- Muriel DORET, Prof.
-
Principal Investigator:
- Muriel Doret, Prof.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
All birth between 24 + 0 weeks of amenorrhea and 36 + 6 weeks of amenorrhea with isolated intrauterine growth restriction at the maternity ward of the hospital Femme-Mère-Enfant from 1st of january 2011 to 31 december 2016.
To each of these children with intrauterine growth restriction is matched a control child: the child without intrauterine growth restriction of the same gestational age whose date of birth is consecutive to that of the case.
Description
Inclusion Criteria:
- All birth between 24 + 0 weeks of amenorrhea and 36 + 6 weeks of amenorrhea
- with isolated intrauterine growth restriction at the maternity ward of the hospital Femme-Mère-Enfant
- from 1st of january 2011 to 31 december 2016.
Inclusion Criteria for control group:
- All birth between 24 + 0 weeks of amenorrhea and 36 + 6 weeks of amenorrhea
- without isolated intrauterine growth restriction at the maternity ward of the hospital Femme-Mère-Enfant
- from 1st of january 2011 to 31 december 2016.
Exclusion Criteria:
- Infants born out of the hospital and secondarily hospitalized in our department
- unaccompanied pregnancies
- multiple pregnancies
- children with malformations or genetic abnormalities,
- medical termination of pregnancy
- fetal deaths in utero
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
IUGR
All birth between 24 + 0 weeks of amenorrhea and 36 + 6 weeks of amenorrhea with isolated intrauterine growth restriction at the maternity ward of the hospital Femme-Mère-Enfant from 1st of january 2011 to 31 december 2016.
|
Collection of necrotizing enterocolitis diagnosis, as well as its severity, are based on the classification of Belle modified in 3 stages: 1) Suspected, 2) Proven, 3) Advanced
|
Control
To each of these children with intrauterine growth restriction is matched a control child: the child without intrauterine growth restriction of the same gestational age whose date of birth is consecutive to that of the case.
|
Collection of necrotizing enterocolitis diagnosis, as well as its severity, are based on the classification of Belle modified in 3 stages: 1) Suspected, 2) Proven, 3) Advanced
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of patients with Necrotizing Enterocolitis stage 1
Time Frame: between 2011 and 2016
|
The necrotizing enterocolitis diagnosis, as well as its severity, are based on the classification of Belle modified in 3 stages: 1) Suspected, 2) Proven, 3) Advanced
|
between 2011 and 2016
|
Number of patients with Necrotizing Enterocolitis stage 2
Time Frame: between 2011 and 2016
|
The necrotizing enterocolitis diagnosis, as well as its severity, are based on the classification of Belle modified in 3 stages: 1) Suspected, 2) Proven, 3) Advanced
|
between 2011 and 2016
|
Number of patients with Necrotizing Enterocolitis stage 3
Time Frame: between 2011 and 2016
|
The necrotizing enterocolitis diagnosis, as well as its severity, are based on the classification of Belle modified in 3 stages: 1) Suspected, 2) Proven, 3) Advanced
|
between 2011 and 2016
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Muriel Doret, ¨Prof., Hospices Civils de Lyon
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ECUN
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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