Acute Abdomen in ChildrenEchoPrémANCT07275268
DIAGNOSTIC CONTRIBUTION OF EARLY ABDOMINAL ULTRASOUND IN THE SITUATION OF ACUTE ABDOMEN OF PREMATURE
A study testing Abdominal Ultrasound in people with Acute Abdomen in Children, run by Centre Hospitalier Universitaire de Besancon.
Trial 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… Read more about this study
- Who is it for?
- Ages Up to 36 weeks
- Conditions the study is for
- Acute Abdomen in Children
- What is being tested?
- Abdominal Ultrasound
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Dec 2025to Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 36 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
- Being tested
- Abdominal Ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abdominal UltrasoundProcedure or surgery
Abdominal Ultrasound
| Study group | Role | What they receive |
|---|---|---|
| Abdominal Ultrasound | Experimental | Abdominal Ultrasound Receives: Procedure: Abdominal Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2025
- Study startDec 2025 (estimated)
- Primary completionJun 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Abdomen in ChildrenStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chloé HILD, MD, Principal investigator, CHU de BesançonMarion AUBER LENOIR, MD, Principal investigator, CHU de Besançon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07275268
- Sponsor's protocol ID
- 2025/979
- Acronym
- EchoPrémA
- Status last verified
- Nov 2025
- First submitted
- 28 Nov 2025
- Last updated
- 10 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DIAGNOSTIC CONTRIBUTION OF EARLY ABDOMINAL ULTRASOUND IN THE SITUATION OF ACUTE ABDOMEN OF PREMATURE
- ClinicalTrials.gov ID
- NCT07275268
- Acronym / sponsor ID
- EchoPrémA / 2025/979
- Conditions
- Acute Abdomen in Children
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- Dec 2025 (estimated)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 10 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Abdominal Ultrasound | Experimental | Procedure: Abdominal UltrasoundAbdominal Ultrasound |
Who may qualify
- Ages
- Up to 36 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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),
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Abdominal UltrasoundAbdominal Ultrasound | Procedure or surgery | Abdominal Ultrasound |
Primary outcome
Presence or absence of echographic signs
Time frame: Day 5
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Chloé HILD, MD principal investigator
CHU de Besançon
Marion AUBER LENOIR, MD principal investigator
CHU de Besançon
Questions about this trial
What is this clinical trial studying?
A study testing Abdominal Ultrasound in people with Acute Abdomen in Children, run by Centre Hospitalier Universitaire de Besancon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Morgane VIDONI AGUILAR, Int (0033 3 81 21 91 61, maguilarrubio@chu-besancon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence or absence of echographic signs (time frame: Day 5). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2025.