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

Not Applicable

• Conditions: the Necrotizing Enterocolitis; Preterm Infants
• Interventions: Device: Abdominal ultrasound

• Registration Number: NCT02872350
• Lead Sponsor: Assistance Publique Hopitaux De Marseille

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2016-08
• Study First Submitted: 2016-08-16
• Study First Submitted QC: 2016-08-16
• Last Update Submitted: 2016-08-16
• Study First Posted: 2016-08-19
• Last Update Posted: 2016-08-19
• Study Start: 2016-10
• Primary Completion: 2019-04
• Study Completion: 2019-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 95

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Premature with necrotizing enterocolitis	Abdominal ultrasound	-

Primary Outcome Measures

Name	Time	Method
Comment prognostic evaluation by abdominal ultrasound	36 months	Assessment in clinical outcome prognosis by abdominal ultrasound

Trial Locations

Locations (1)

Assistance Publique Hôpitaux de Marseille; 🇫🇷 Marseille, France