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

C

Centre Hospitalier Universitaire de Besancon

Status

Not yet enrolling

Conditions

Acute Abdomen in Children

Treatments

Procedure: Abdominal Ultrasound

Study type

Interventional

Funder types

Other

Identifiers

NCT07275268
2025/979

Details and patient eligibility

About

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).

Enrollment

100 estimated patients

Sex

All

Ages

Under 36 weeks old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

100 participants in 1 patient group

Abdominal Ultrasound
Experimental group
Description:
Abdominal Ultrasound
Treatment:
Procedure: Abdominal Ultrasound

Trial contacts and locations

0

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Central trial contact

Morgane VIDONI AGUILAR, Int

Data sourced from clinicaltrials.gov

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