- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05882448
Study of the Influence of Intraperitoneal Insufflation of CO2 by Laparoscopy on the Short-term Evolution of Premature Infants With Ulcerative Necrotizing Enterocolitis (NECO2)
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
Ulcerative-necrotizing enterocolitis (ECUN) is an infectious and inflammatory disease of the digestive tract, which can lead to intestinal necrosis or perforation.
This severe pathology of the newborn , often premature, requires urgent medical and surgical treatment in 25 to 50% of cases. The morbidity is high, both digestive and neurological. ECUN can lead to complications at short-term (death, intestinal stenosis) and at long-term (neuro-cognitive disorders). The challenge of preserving the neurological development is a major issue. It involves control of inflammation. This inflammation causes neurological lesions and is responsible for a disorder of the long-term neurocognitive development.
At Robert-Debré and Trousseau, the management of newborns with ECUN is focused on the control of this inflammation. A laparoscopy is performed first. The carbon dioxide (CO2) insufflated into the abdomen during a laparoscopy is thought to have an anti-inflammatory effect according to several experimental and clinical studies. A preliminary retrospective study at Robert-Debré showed a decrease in postoperative inflammation (decrease in C reactive protein at Day2 and Day 7 post-op) as well as a decrease in morbimortality (decrease in the rate of stoma and reoperation) in children who had a laparoscopic first operation compared to those who had a laparotomy alone. However, in many hospitals, laparotomy alone is currently the only surgical option.
This preliminary study may demonstrate that laparoscopy decreases early morbidity and mortality in children with ECUN through reduced inflammation, as reflected by postoperative C reactive protein.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
NECO2 is a pilot trial, evaluating the intermediate effectiveness to short/medium term of laparoscopy on the inflammatory reaction of premature newborns with complicated ECUN, requiring surgical treatment.
This is a multicenter randomized controlled trial in single blind, in two parallel arms, in ratio 1:1, of superiority.
This trial compares laparoscopy plus laparotomy versus laparotomy alone.
Children will be randomized into 2 groups:
- Laparoscopy + laparotomy group
- Laparotomy group
The main objective is to evaluate the inflammatory response Day 2 postoperative in preterm infants with ECUN who have undergone surgery.
The main criterion is the evolution of the blood C reactive protein level between Day 0 and Day 2 postoperatively.
The secondary objectives are:To evaluate in premature babies with ECUN who have had a surgical intervention (laparoscopy + laparotomy or laparotomy alone):
A.The postoperative biological inflammatory response at Day 7 B.Post-operative biological inflammatory response from Day 0 to Day 7 C.Post-operative mortality D.Post-operative bowel morbidity E.Post-operative re-intervention rate F.Length of hospital stay G.Post-operative neurological morbidity, medium term (corrected term 41 SA)
- To evaluate the tolerance of laparoscopy :
H.Intraoperative cardiorespiratory I.Loco-regional lesions linked to the insertion of the trocar
Secondary endpoints:
A. C reactive protein blood level at Day 7 B. Blood levels of Procalcitonin, Interleukin 6 and Tumor Necrosis Factor-alpha at Day 1, Day 2, Day 4, Day 7 C. Postoperative death from any cause D. Stoma rate, duration of parenteral nutrition, duration of hemodynamic support, duration of invasive ventilation (High frequency oscillatory ventilation/Synchronized Intermittent Mandatory Ventilation), Post-ECUN intestinal stenosis rate E. Re-intervention (laparotomy) and cause (post-ECUN stenosis, stoma closure) F. Length of hospital stay until return home G. Early postoperative neurological lesions observed on transfontanellar ultrasound and MRI at the corrected term of 41 weeks of amenorrhea, H. Oxygen saturation (SaO2), hypercapnia (pCO2) blood pressure (BP), cerebral oxygenation (Near InfraRed Spectroscopy (NIRS)) intraoperatively I. Intraoperative clinical monitoring: exploration of adjacent organs. Post-operative clinical monitoring: digestive signs monitoring of wounds until discharge.
Group 1: laparotomy only Group 2: laparotomy and laparoscopy
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Louise MONTALVA, Dr
- Phone Number: +33 1.71.73.89.97
- Email: louise.montalva@aphp.fr
Study Contact Backup
- Name: Arnaud BONNARD, Pr
- Phone Number: +33 1 40 03 23 59
- Email: arnaud.bonnard@aphp.fr
Study Locations
-
-
-
Paris, France, 75012
- Recruiting
- Hôpital Armand Trousseau Service de Chirurgie Pédiatrique et Néonatale
-
Contact:
- MONTALVA Louise, Dr
- Phone Number: +33 +33 1.71.73.89.97
- Email: louise.montalva@aphp.fr
-
Paris, France
- Recruiting
- Hôpital Robert Debré Service de Chirurgie Pédiatrique
-
Contact:
- BONNARD Arnaud, Pr
- Phone Number: +33 33 1 40 03 41 21
- Email: arnaud.bonnard@aphp.fr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Laparotomy
Exploratory and therapeutic laparotomy if necessary, in case of necrotic intestine requiring resection with anastomosis or stoma-type bowel diversion
|
Exploratory and therapeutic laparotomy if necessary, in case of necrotic intestine requiring resection with anastomosis or stoma-type bowel diversion
|
Experimental: Laparotomy and laparoscopy
Exploratory and therapeutic laparotomy if necessary preceded by laparoscopy with insufflation of CO2 (placement of a 3mm trocar in the left hypochondrium and insufflation of a pneumoperitoneum (carbon dioxide, pressure: 6 mmHg, flow rate: 1.5 Liter/minute) for a duration of at least 5 minutes.
|
Exploratory and therapeutic laparotomy if necessary, in case of necrotic intestine requiring resection with anastomosis or stoma-type bowel diversion
laparoscopy with insufflation of CO2 (placement of a 3mm trocar in the left hypochondrium and insufflation of a pneumoperitoneum (carbon dioxide, pressure: 6 mmHg, flow rate: 1.5 Liter/minute) for a duration of at least 5 minutes.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
C reactive protein blood level
Time Frame: between Day 0 and Day 2 post surgery
|
C reactive protein blood level
|
between Day 0 and Day 2 post surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Postoperative biological inflammatory reaction
Time Frame: Day 7 post surgery
|
C reactive protein blood level
|
Day 7 post surgery
|
Specific post-operative biological inflammatory reaction
Time Frame: Day1, day 2, day 4 and day 7 post surgery
|
Procalcitonin, Interleukin 6 and Tumor Necrosis Factor-alpha blood level
|
Day1, day 2, day 4 and day 7 post surgery
|
Postoperative mortality
Time Frame: up to 3 months
|
Death due to any postoperative cause
|
up to 3 months
|
Postoperative intestinal morbidity: stoma rate
Time Frame: up to 3 months
|
Stoma rate
|
up to 3 months
|
Postoperative intestinal morbidity: Duration of parenteral nutrition
Time Frame: up to 3 months
|
Duration of parenteral nutrition
|
up to 3 months
|
Postoperative intestinal morbidity: Duration of hemodynamic support
Time Frame: up to 3 months
|
Duration of hemodynamic support
|
up to 3 months
|
Postoperative intestinal morbidity: Duration of invasive ventilation (HFO: High frequency oscillatory ventilation/VACI: Synchronized Intermittent Mandatory Ventilation)
Time Frame: up to 3 months
|
Duration of invasive ventilation (HFO: High frequency oscillatory ventilation/VACI: Synchronized Intermittent Mandatory Ventilation)
|
up to 3 months
|
Postoperative intestinal morbidity: Rate of intestinal stenosis post-ECUN
Time Frame: up to 3 months
|
Rate of intestinal stenosis post-ECUN
|
up to 3 months
|
Postoperative reoperation rate
Time Frame: up to 3 months
|
Reoperation (laparotomy) and cause (post ECUN stenosis, stoma closure)
|
up to 3 months
|
Length of hospitalization
Time Frame: up to 3 months
|
Duration of hospitalization until return home
|
up to 3 months
|
Medium-term postoperative neurological morbidity
Time Frame: up to 3 months
|
Early postoperative neurological lesions observed on transfontanellar ultrasound and MRI at term corrected for 41 weeks of amenorrhea
|
up to 3 months
|
Oxygen saturation (SaO2) (Tolerance of laparoscopy (Intraoperative cardio-respiratory))
Time Frame: During Surgery
|
Oxygen saturation (SaO2)
|
During Surgery
|
Hypercapnia (pCO2) (Tolerance of laparoscopy (Intraoperative cardio-respiratory))
Time Frame: During Surgery
|
hypercapnia (pCO2)
|
During Surgery
|
Blood pressure (BP) (Tolerance of laparoscopy (Intraoperative cardio-respiratory))
Time Frame: During Surgery
|
blood pressure (systolic and diastolic)
|
During Surgery
|
Cerebral oxygenation (Near InfraRed Spectroscopy (NIRS)) (Tolerance of laparoscopy (Intraoperative cardio-respiratory))
Time Frame: During Surgery
|
cerebral oxygenation (Near InfraRed Spectroscopy (NIRS)) intraoperatively
|
During Surgery
|
Presence of loco-regional lesions related to the insertion of the trocar (Tolerance of laparoscopy)
Time Frame: up to 3 months
|
Presence of loco-regional lesions related to the insertion of the trocar
|
up to 3 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Gastrointestinal Diseases
- Gastroenteritis
- Intestinal Diseases
- Pregnancy Complications
- Obstetric Labor Complications
- Obstetric Labor, Premature
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Premature Birth
- Enterocolitis
- Enterocolitis, Necrotizing
Other Study ID Numbers
- APHP221170
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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