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

NCT ID: NCT07275268

Last Updated: 2025-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-31

Study Completion Date

2028-06-30

Brief Summary

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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).

Detailed Description

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Conditions

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Acute Abdomen in Children

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Abdominal Ultrasound

Abdominal Ultrasound

Group Type EXPERIMENTAL

Abdominal Ultrasound

Intervention Type PROCEDURE

Abdominal Ultrasound

Interventions

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Abdominal Ultrasound

Abdominal Ultrasound

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Maximum Eligible Age

36 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Besancon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Chloé HILD, MD

Role: PRINCIPAL_INVESTIGATOR

CHU de Besançon

Marion AUBER LENOIR, MD

Role: PRINCIPAL_INVESTIGATOR

CHU de Besançon

Central Contacts

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Morgane VIDONI AGUILAR, Int

Role: CONTACT

0033 3 81 21 91 61

Other Identifiers

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2025/979

Identifier Type: -

Identifier Source: org_study_id

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