Using CO2 Insufflation During Laparoscopy to Treat Premature Infants with Severe Intestinal Inflammation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pilot trial evaluates the effectiveness of laparoscopic surgery combined with laparotomy in treating premature infants suffering from ulcerative necrotizing enterocolitis (ECUN). The study involves a multicenter randomized controlled design where infants are assigned to either receive both laparoscopic and laparotomy procedures or laparotomy alone. The primary focus is on measuring the inflammatory response through blood C-reactive protein levels post-surgery. Secondary objectives include assessing various postoperative outcomes such as mortality, bowel morbidity, and neurological impacts.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Premature newborn (term of birth: \<37 weeks of amenorrhea)
* Diagnosis of ECUN by the surgeon (distension abdominal +/- rectal bleeding +/- green gastric residue, increased biological inflammatory syndrome, + pneumatosis on abdominal radiography)
* Hospitalized and complicated ECUN: presenting either a pneumoperitoneum on abdominal X-ray or a absence of clinical and biological improvement after 48 hours of maximum well-conducted medical treatment (IV antibiotic therapy and digestive rest).
* Hospitalized in the 2 participating centers
* Of which the 2 holders of parental authority have been informed and have signed the consent form
* Having social security coverage (social security or CMU)

Exclusion Criteria:

* Instability contraindicating movement to the operating room or contraindicating CO2 insufflation
* Diagnosis of isolated perforation of the small intestine (radiography:

pneumoperitoneum without pneumatosis)

Where it's running

• Hôpital Armand Trousseau Service de Chirurgie Pédiatrique et Néonatale
  Paris, France Recruiting
• Hôpital Robert Debré Service de Chirurgie Pédiatrique
  Paris, France Recruiting

Study contacts

• Study coordinator: Louise MONTALVA, Dr
• Email: louise.montalva@aphp.fr
• Phone: +33 1.71.73.89.97

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.