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NCT Number: NCT07275268

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

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).

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Key information

Conditions

Acute Abdomen in Children

Age range

Up to 36 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Abdominal ultrasound

Procedure

Abdominal Ultrasound

Primary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Morgane VIDONI AGUILAR, Int

CONTACT

[email protected]

0033 3 81 21 91 61

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Besancon

Other

Registry information

Acronym: EchoPrémA

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Dec 10, 2025
Registry last updated
Dec 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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