Prognostic Contribution of Abdominal Ultrasound in Necrotizing Enterocolitis in Preterm Infants Less Than 33SA. (ECUN)
Primary Purpose
the Necrotizing Enterocolitis, Preterm Infants
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Abdominal ultrasound
Sponsored by
About this trial
This is an interventional diagnostic trial for the Necrotizing Enterocolitis
Eligibility Criteria
Inclusion Criteria:
- Birth Term strictly less than 33SA
- Gestational age some (assessed on early ultrasound dating)
- Congenital malformation of Absence
- Suggestive clinical symptomatology of ECUN defined by the presence of abdominal bloating, increased residues (> 20% of the volume of enteral feeding) and the presence of blood in stool (macro- or microscopic)
- Radiologic investigation with a radiograph of abdomen and abdominal ultrasound done for the episode of ECUN
- Maximum interval between imaging tests 2 hours
- No parental opposition to the participation of children in the study
Exclusion Criteria:
- Term higher or equal to 33 weeks
- Congenital malformation
- Parental Opposition (or legal representatives) to participate in the study
Sites / Locations
- Assistance Publique Hôpitaux de Marseille
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Premature with necrotizing enterocolitis
Arm Description
Outcomes
Primary Outcome Measures
Comment prognostic evaluation by abdominal ultrasound
Assessment in clinical outcome prognosis by abdominal ultrasound
Secondary Outcome Measures
Full Information
NCT ID
NCT02872350
First Posted
August 16, 2016
Last Updated
August 16, 2016
Sponsor
Assistance Publique Hopitaux De Marseille
1. Study Identification
Unique Protocol Identification Number
NCT02872350
Brief Title
Prognostic Contribution of Abdominal Ultrasound in Necrotizing Enterocolitis in Preterm Infants Less Than 33SA.
Acronym
ECUN
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Unknown status
Study Start Date
October 2016 (undefined)
Primary Completion Date
April 2019 (Anticipated)
Study Completion Date
April 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique Hopitaux De Marseille
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Enterocolitis necrotizing (ECUN) is a common and serious gastrointestinal disease in premature infants.
The diagnosis of ECUN based on clinical and radiological criteria. The abdomen plain film to date is the reference examination to confirm or refute the diagnosis. Indeed, the presence of pathognomonic signs (pneumatosis, aéroportie) on the abdomen of cliché can confirm the diagnosis. The prognostic value of these radiographic findings is currently controversial.
Abdominal ultrasound is a test whose possibilities in diagnostic and prognostic term began to be considered for some years. It also has other advantages, including that of not being a radiating examination. Studies on the prognostic value of abdominal ultrasound are rather few. Moreover, they involve a series of heterogeneous patients in terms of gestational age. Or the pathophysiology of ECUN in children born at term and in children born prematurely is not the same.
The objective is to study prospectively the prognostic contribution of abdominal ultrasound in the ECUN in premature under 33SA.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
the Necrotizing Enterocolitis, Preterm Infants
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
95 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Premature with necrotizing enterocolitis
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Abdominal ultrasound
Intervention Description
Techniques and predictive characteristics of the combination abdominal ultrasound abdomen and shot in the prognostic assessment of ECUN in premature under 33SA.
Primary Outcome Measure Information:
Title
Comment prognostic evaluation by abdominal ultrasound
Description
Assessment in clinical outcome prognosis by abdominal ultrasound
Time Frame
36 months
10. Eligibility
Sex
All
Maximum Age & Unit of Time
33 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Birth Term strictly less than 33SA
Gestational age some (assessed on early ultrasound dating)
Congenital malformation of Absence
Suggestive clinical symptomatology of ECUN defined by the presence of abdominal bloating, increased residues (> 20% of the volume of enteral feeding) and the presence of blood in stool (macro- or microscopic)
Radiologic investigation with a radiograph of abdomen and abdominal ultrasound done for the episode of ECUN
Maximum interval between imaging tests 2 hours
No parental opposition to the participation of children in the study
Exclusion Criteria:
Term higher or equal to 33 weeks
Congenital malformation
Parental Opposition (or legal representatives) to participate in the study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aurelie GARBI, PH
Phone
0491968300
Email
aurelie.garbi@ap-hm.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Urielle DESALBRES, Director
Phone
01491382747
Email
drci@ap-hm.fr
Facility Information:
Facility Name
Assistance Publique Hôpitaux de Marseille
City
Marseille
ZIP/Postal Code
13354
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aurelie GARBI, PH
Phone
0491968300
Email
aurelie.garbi@ap-hm.fr
First Name & Middle Initial & Last Name & Degree
Urielle DESALBRES, Director
Phone
0491382747
Email
drci@ap-hm.fr
First Name & Middle Initial & Last Name & Degree
Aurelie GARBI, PH
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Prognostic Contribution of Abdominal Ultrasound in Necrotizing Enterocolitis in Preterm Infants Less Than 33SA.
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