DIAGNOSTIC CONTRIBUTION OF EARLY ABDOMINAL ULTRASOUND IN THE SITUATION OF ACUTE ABDOMEN OF PREMATURE (NCT07275268) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
DIAGNOSTIC CONTRIBUTION OF EARLY ABDOMINAL ULTRASOUND IN THE SITUATION OF ACUTE ABDOMEN OF PREMATURE
100 participantsStarted 2025-12
Plain-language 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).
Who can participate
Age range
36 Weeks
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Presence or absence of echographic signs
Timeframe: Day 5
Trial details
NCT IDNCT07275268
SponsorCentre Hospitalier Universitaire de Besancon