An interventional study of laparotomy and Laparoscopy in Preterm Birth and Enterocolitis, Necrotizing, sponsored by Assistance Publique - Hôpitaux de Paris. Recruiting at 2 sites in France. Per ClinicalTrials.gov, last updated 2026-11-06.
Sponsored by Assistance Publique - Hôpitaux de Paris · Not applicable, Interventional, and Treatment
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.
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:
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)
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
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This study's planned enrollment of 54 is below the median of 84 across 1,666 interventional studies indexed under Premature Birth.
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Exclusion Criteria:
pneumoperitoneum without pneumatosis)
Exploratory and therapeutic laparotomy if necessary, in case of necrotic intestine requiring resection with anastomosis or stoma-type bowel diversion
Procedure: laparotomy
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.
Procedure: laparotomy · Procedure: Laparoscopy
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.
C reactive protein blood level
C reactive protein blood level
Time frame: between Day 0 and Day 2 post surgery
Postoperative biological inflammatory reaction
C reactive protein blood level
Time frame: Day 7 post surgery
Specific post-operative biological inflammatory reaction
Procalcitonin, Interleukin 6 and Tumor Necrosis Factor-alpha blood level
Time frame: Day1, day 2, day 4 and day 7 post surgery
Postoperative mortality
Death due to any postoperative cause
Time frame: up to 3 months
Postoperative intestinal morbidity: stoma rate
Stoma rate
Time frame: up to 3 months
Postoperative intestinal morbidity: Duration of parenteral nutrition
Duration of parenteral nutrition
Time frame: up to 3 months
Postoperative intestinal morbidity: Duration of hemodynamic support
Duration of hemodynamic support
Time frame: up to 3 months
Postoperative intestinal morbidity: Duration of invasive ventilation (HFO: High frequency oscillatory ventilation/VACI: Synchronized Intermittent Mandatory Ventilation)
Duration of invasive ventilation (HFO: High frequency oscillatory ventilation/VACI: Synchronized Intermittent Mandatory Ventilation)
Time frame: up to 3 months
Postoperative intestinal morbidity: Rate of intestinal stenosis post-ECUN
Rate of intestinal stenosis post-ECUN
Time frame: up to 3 months
Postoperative reoperation rate
Reoperation (laparotomy) and cause (post ECUN stenosis, stoma closure)
Time frame: up to 3 months
Length of hospitalization
Duration of hospitalization until return home
Time frame: up to 3 months
Medium-term postoperative neurological morbidity
Early postoperative neurological lesions observed on transfontanellar ultrasound and MRI at term corrected for 41 weeks of amenorrhea
Time frame: up to 3 months
Oxygen saturation (SaO2) (Tolerance of laparoscopy (Intraoperative cardio-respiratory))
Oxygen saturation (SaO2)
Time frame: During Surgery
Hypercapnia (pCO2) (Tolerance of laparoscopy (Intraoperative cardio-respiratory))
hypercapnia (pCO2)
Time frame: During Surgery
Blood pressure (BP) (Tolerance of laparoscopy (Intraoperative cardio-respiratory))
blood pressure (systolic and diastolic)
Time frame: During Surgery
Cerebral oxygenation (Near InfraRed Spectroscopy (NIRS)) (Tolerance of laparoscopy (Intraoperative cardio-respiratory))
cerebral oxygenation (Near InfraRed Spectroscopy (NIRS)) intraoperatively
Time frame: During Surgery
Presence of loco-regional lesions related to the insertion of the trocar (Tolerance of laparoscopy)
Presence of loco-regional lesions related to the insertion of the trocar
Time frame: up to 3 months
Plan to share: Undecided
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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