DIAGNOSTIC CONTRIBUTION OF EARLY ABDOMINAL ULTRASOUND IN THE SITUATION OF ACUTE ABDOMEN OF PREMATURE (EchoPrémA)

This study will assess the diagnostic contribution of early abdominal ultrasound for acute abdomen in premature newborns.

Early ultrasound assessment would provide diagnostic assistance, in conjunction with clinical examination and biological testing, in the three main clinical situations encountered with an acute abdomen in premature infants: enterocolitis (digestive translocation of a bacterium secondary to inflammation, local fragility of the digestive tract, associated ischemic phenomena), reflex ileus (decrease in intestinal peristalsis secondary to peritoneal reactivity following inflammatory phenomena) and digestive immaturity (expressed by bloating, regurgitation, absence of spontaneous transit, related to the degree of prematurity).

Study Overview

• Status: Not yet recruiting
• Conditions: Acute Abdomen in Children
• Intervention / Treatment: Procedure: Abdominal Ultrasound

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Morgane VIDONI AGUILAR, Int; Phone Number: 0033 3 81 21 91 61; Email: maguilarrubio@chu-besancon.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Premature under 37 weeks of amenorrhea with an adverse event of special interest such as :

• altered abdomen with bloating or presence of previsouly unknow marked collateral circulation,
• absence of spontaneous transit (> 48 hours),
• episode of rectal bleeding,
• repeated regurgitation/vomiting (during more than 50% of feedings),
• prolonged fasting (>12 hours), OR
• increase in cardiorespiratory events on continuous monitoring associated with one of the elements listed above.

Exclusion Criteria:

• organic malformation detected during prenatal monitoring or discovered in the immediate postnatal period,
• chromosomal abnormality detected during prenatal monitoring or discovered in the immediate postnatal period,- spontaneous perforation occurring during the first week of life.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Abdominal Ultrasound	Procedure: Abdominal Ultrasound; Abdominal Ultrasound

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Presence or absence of echographic signs	Presence of "positive" echographic signs such as: aeroportia, pneumatosis parietalis, pneumoperitoneum, bowel wall thickening, fluid effusion, distension of bowel loops, during the early echography for premature newborns with digestive symptomatology.	Day 5

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Besancon
• Investigators: Principal Investigator: Chloé HILD, MD, CHU de Besancon; Principal Investigator: Marion AUBER LENOIR, MD, CHU de Besancon

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2025
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028

Study Registration Dates

• First Submitted: November 28, 2025
• First Submitted That Met QC Criteria: November 28, 2025
• First Posted (Actual): December 10, 2025

Study Record Updates

• Last Update Posted (Actual): December 10, 2025
• Last Update Submitted That Met QC Criteria: November 28, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 2025/979

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No