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

Preterm Infants Clinical Trial

— ECUN  

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02872350
• Other study ID #: 2015-34
• Secondary ID: 2015-A01628-41
• Status: Not yet recruiting
• Phase: N/A
• First received: August 16, 2016
• Last updated: August 16, 2016
• Start date: October 2016
• Est. completion date: April 2019

Study information

• Verified date: August 2016
• Source: Assistance Publique Hopitaux De Marseille
• Contact: Aurelie GARBI, PH
• Phone: 0491968300
• Email: aurelie.garbi[@]ap-hm.fr
• Is FDA regulated: No
• Health authority: France: The Commission nationale de l’informatique et des libertés
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 95
• Est. completion date: April 2019
• Est. primary completion date: April 2019
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 33 Weeks

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Enterocolitis
• Enterocolitis, Necrotizing
• Premature Birth
• Preterm Infants
• the Necrotizing Enterocolitis

Intervention

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

Locations

Country	Name	City	State
France	Assistance Publique Hôpitaux de Marseille	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comment prognostic evaluation by abdominal ultrasound	Assessment in clinical outcome prognosis by abdominal ultrasound	36 months	No