Skip to content

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02872350
Acronym
ECUN
Enrollment
95
Registered
2016-08-19
Start date
2016-10-31
Completion date
2019-04-30
Last updated
2016-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Preterm Infants, the Necrotizing Enterocolitis

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.

Interventions

DEVICEAbdominal ultrasound

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

Sponsors

Assistance Publique Hopitaux De Marseille
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
No minimum to 33 Weeks
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Comment prognostic evaluation by abdominal ultrasound36 monthsAssessment in clinical outcome prognosis by abdominal ultrasound

Countries

France

Contacts

Primary ContactAurelie GARBI, PH
aurelie.garbi@ap-hm.fr0491968300
Backup ContactUrielle DESALBRES, Director
drci@ap-hm.fr01491382747

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026