Prognostic Contribution of Abdominal Ultrasound in Necrotizing Enterocolitis in Preterm Infants Less Than 33SA.

NCT ID: NCT02872350

Last Updated: 2016-08-19

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

95 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-31

Study Completion Date

2019-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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the Necrotizing Enterocolitis Preterm Infants

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Premature with necrotizing enterocolitis

Group Type EXPERIMENTAL

Abdominal ultrasound

Intervention Type DEVICE

Techniques and predictive characteristics of the combination abdominal ultrasound abdomen and shot in the prognostic assessment of ECUN in premature under 33SA.

Interventions

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Abdominal ultrasound

Techniques and predictive characteristics of the combination abdominal ultrasound abdomen and shot in the prognostic assessment of ECUN in premature under 33SA.

Intervention Type DEVICE

Eligibility Criteria

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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
Maximum Eligible Age

33 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assistance Publique Hopitaux De Marseille

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Assistance Publique Hôpitaux de Marseille

Marseille, , France

Site Status

Countries

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France

Central Contacts

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Aurelie GARBI, PH

Role: CONTACT

0491968300

Urielle DESALBRES, Director

Role: CONTACT

01491382747

Facility Contacts

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Aurelie GARBI, PH

Role: primary

0491968300

Urielle DESALBRES, Director

Role: backup

0491382747

Other Identifiers

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2015-A01628-41

Identifier Type: REGISTRY

Identifier Source: secondary_id

2015-34

Identifier Type: -

Identifier Source: org_study_id

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