Using CO2 Insufflation During Laparoscopy to Treat Premature Infants with Severe Intestinal Inflammation
Study of the Influence of Intraperitoneal Insufflation of Carbon Dioxide (CO2) by Laparoscopy on the Short-term Evolution of Premature Infants With Ulcerative Necrotizing Enterocolitis
This study is testing if a combination of two types of surgery can help premature infants with severe intestinal inflammation feel better and recover more effectively than just one type of surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 54 (estimated) |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 2 sites (Paris and 1 other locations) |
| Trial ID | NCT05882448 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are premature newborns under 37 weeks of gestation diagnosed with complicated ECUN requiring surgical intervention.
Not a fit: Patients with isolated small intestine perforation or those unstable for surgery will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce inflammation and improve recovery outcomes for premature infants with ECUN.
How similar studies have performed: While the specific use of CO2 insufflation in this context is novel, similar approaches in managing inflammation during surgery have shown promise in other studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Paris and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.