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

NCT07275268 | Not Yet Recruiting

• 1 other identifier: 2025/979
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

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).

Conditions

Acute Abdomen in Children

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Abdominal Ultrasound

EXPERIMENTAL

Abdominal Ultrasound

Procedure: Abdominal Ultrasound

Interventions

Abdominal Ultrasound PROCEDURE

Abdominal Ultrasound

Abdominal Ultrasound

Eligibility Criteria

• Age: Up to 36 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Besancon: lead

Study Officials

• Chloé HILD, MD

  CHU de Besançon

  PRINCIPAL INVESTIGATOR

• Marion AUBER LENOIR, MD

  CHU de Besançon

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Morgane VIDONI AGUILAR, Int

CONTACT

0033 3 81 21 91 61; maguilarrubio@chu-besancon.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2025
• First Posted: December 10, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: December 10, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share