Ignite Creation Date:
2024-05-06 @ 7:05 PM
Last Modification Date:
2024-10-26 @ 2:59 PM
Study NCT ID:
NCT05882448
Status:
RECRUITING
Last Update Posted:
2024-02-28
First Post:
2023-04-24
Brief Title:
Study of the Influence of Intraperitoneal Insufflation of CO2 by Laparoscopy on the Short-term Evolution of Premature Infants With Ulcerative Necrotizing Enterocolitis
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
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
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NECO2
Brief Summary:
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
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
Detailed Description:
NECO2 is a pilot trial evaluating the intermediate effectiveness to shortmedium 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 11 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 areTo evaluate in premature babies with ECUN who have had a surgical intervention laparoscopy laparotomy or laparotomy alone
AThe postoperative biological inflammatory response at Day 7 BPost-operative biological inflammatory response from Day 0 to Day 7 CPost-operative mortality DPost-operative bowel morbidity EPost-operative re-intervention rate FLength of hospital stay GPost-operative neurological morbidity medium term corrected term 41 SA
To evaluate the tolerance of laparoscopy
HIntraoperative cardiorespiratory ILoco-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 ventilationSynchronized 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
This is a multicenter randomized controlled trial in single blind in two parallel arms in ratio 11 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 areTo evaluate in premature babies with ECUN who have had a surgical intervention laparoscopy laparotomy or laparotomy alone
AThe postoperative biological inflammatory response at Day 7 BPost-operative biological inflammatory response from Day 0 to Day 7 CPost-operative mortality DPost-operative bowel morbidity EPost-operative re-intervention rate FLength of hospital stay GPost-operative neurological morbidity medium term corrected term 41 SA
To evaluate the tolerance of laparoscopy
HIntraoperative cardiorespiratory ILoco-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 ventilationSynchronized 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None