Preterm BirthNECO2NCT05882448
Study of the Influence of Intraperitoneal Insufflation of CO2 by Laparoscopy on the Short-term Evolution of Premature Infants With Ulcerative Necrotizing Enterocolitis
A study testing laparotomy and Laparoscopy in people with Preterm Birth and Enterocolitis, Necrotizing, run by Assistance Publique - Hôpitaux de Paris at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Preterm Birth, Enterocolitis, Necrotizing
- What is being tested?
- laparotomy and Laparoscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 2 sitesFrance
- Study dates
- 22 Feb 2024to 22 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Instability contraindicating movement to the operating room or contraindicating CO2 insufflation
- Diagnosis of isolated perforation of the small intestine (radiography:
- pneumoperitoneum without pneumatosis)
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Recruiting
Hôpital Armand Trousseau Service de Chirurgie Pédiatrique et Néonatale
Paris, 75012
MONTALVA Louise, Dr, +33 1.71.73.89.97 ext. +33, louise.montalva@aphp.fr
- Recruiting
Hôpital Robert Debré Service de Chirurgie Pédiatrique
Paris
BONNARD Arnaud, Pr, 33 1 40 03 41 21 ext. +33, arnaud.bonnard@aphp.fr
About this study
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
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.
Read more
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.
Read the 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:
- 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
- Conditions
- Preterm Birth, Enterocolitis, Necrotizing
- Being tested
- laparotomy, Laparoscopy
- Medical subject headings
- Premature Birth, Enterocolitis, Necrotizing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laparotomyProcedure or surgery
Exploratory and therapeutic laparotomy if necessary, in case of necrotic intestine requiring resection with anastomosis or stoma-type bowel diversion
LaparoscopyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Laparotomy | Active comparator | Exploratory and therapeutic laparotomy if necessary, in case of necrotic intestine requiring resection with anastomosis or stoma-type bowel diversion Receives: Procedure: laparotomy |
| Laparotomy and laparoscopy | Experimental | 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. Receives: Procedure: laparotomy; Procedure: Laparoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
C reactive protein blood level
C reactive protein blood level
Measured: between Day 0 and Day 2 post surgery
Secondary outcomes (16)
Postoperative biological inflammatory reaction
C reactive protein blood level
Measured: Day 7 post surgery
Specific post-operative biological inflammatory reaction
Procalcitonin, Interleukin 6 and Tumor Necrosis Factor-alpha blood level
Measured: Day1, day 2, day 4 and day 7 post surgery
Postoperative mortality
Death due to any postoperative cause
Measured: up to 3 months
Postoperative intestinal morbidity: stoma rate
Stoma rate
Measured: up to 3 months
Postoperative intestinal morbidity: Duration of parenteral nutrition
Duration of parenteral nutrition
Measured: up to 3 months
Postoperative intestinal morbidity: Duration of hemodynamic support
Duration of hemodynamic support
Measured: 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)
Measured: up to 3 months
Postoperative intestinal morbidity: Rate of intestinal stenosis post-ECUN
Rate of intestinal stenosis post-ECUN
Measured: up to 3 months
Postoperative reoperation rate
Reoperation (laparotomy) and cause (post ECUN stenosis, stoma closure)
Measured: up to 3 months
Length of hospitalization
Duration of hospitalization until return home
Measured: 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
Measured: up to 3 months
Oxygen saturation (SaO2) (Tolerance of laparoscopy (Intraoperative cardio-respiratory))
Oxygen saturation (SaO2)
Measured: During Surgery
Hypercapnia (pCO2) (Tolerance of laparoscopy (Intraoperative cardio-respiratory))
hypercapnia (pCO2)
Measured: During Surgery
Blood pressure (BP) (Tolerance of laparoscopy (Intraoperative cardio-respiratory))
blood pressure (systolic and diastolic)
Measured: During Surgery
Cerebral oxygenation (Near InfraRed Spectroscopy (NIRS)) (Tolerance of laparoscopy (Intraoperative cardio-respiratory))
cerebral oxygenation (Near InfraRed Spectroscopy (NIRS)) intraoperatively
Measured: 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
Measured: up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2023
- Study start22 Feb 2024
- Primary completion22 Jun 2025
- Study completion22 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm BirthStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- parallel assignment
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05882448
- Sponsor's protocol ID
- APHP221170
- Acronym
- NECO2
- Status last verified
- Nov 2026
- First submitted
- 24 Apr 2023
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05882448
- Acronym / sponsor ID
- NECO2 / APHP221170
- Conditions
- Preterm Birth, Enterocolitis, Necrotizing
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 22 Feb 2024 (actual)
- Primary completion
- 22 Jun 2025 (actual)
- Study completion
- 22 Sep 2027 (estimated)
- First posted
- 31 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- parallel assignment
| Arm | Type | Receives |
|---|---|---|
| Laparotomy | Active comparator | Procedure: laparotomyExploratory and therapeutic laparotomy if necessary, in case of necrotic intestine requiring resection with anastomosis or stoma-type bowel diversion |
| Laparotomy and laparoscopy | Experimental | Procedure: laparotomy, Procedure: LaparoscopyExploratory 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- Instability contraindicating movement to the operating room or contraindicating CO2 insufflation
- Diagnosis of isolated perforation of the small intestine (radiography:
- pneumoperitoneum without pneumatosis)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| laparotomyExploratory and therapeutic laparotomy if necessary, in case of necrotic intestine requiring resection with anastomosis or stoma-type bowel diversion | Procedure or surgery | Laparotomy, Laparotomy and laparoscopy |
| Laparoscopylaparoscopy 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 or surgery | Laparotomy and laparoscopy |
Primary outcome
C reactive protein blood level
Time frame: between Day 0 and Day 2 post surgery
C reactive protein blood level
16 secondary outcomes
Postoperative biological inflammatory reaction
Time frame: Day 7 post surgery
Specific post-operative biological inflammatory reaction
Time frame: Day1, day 2, day 4 and day 7 post surgery
Postoperative mortality
Time frame: up to 3 months
Postoperative intestinal morbidity: stoma rate
Time frame: up to 3 months
Postoperative intestinal morbidity: Duration of parenteral nutrition
Time frame: up to 3 months
Postoperative intestinal morbidity: 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)
Time frame: up to 3 months
Postoperative intestinal morbidity: Rate of intestinal stenosis post-ECUN
Time frame: up to 3 months
Postoperative reoperation rate
Time frame: up to 3 months
Length of hospitalization
Time frame: up to 3 months
Medium-term postoperative neurological morbidity
Time frame: up to 3 months
Oxygen saturation (SaO2) (Tolerance of laparoscopy (Intraoperative cardio-respiratory))
Time frame: During Surgery
Hypercapnia (pCO2) (Tolerance of laparoscopy (Intraoperative cardio-respiratory))
Time frame: During Surgery
Blood pressure (BP) (Tolerance of laparoscopy (Intraoperative cardio-respiratory))
Time frame: During Surgery
Cerebral oxygenation (Near InfraRed Spectroscopy (NIRS)) (Tolerance of laparoscopy (Intraoperative cardio-respiratory))
Time frame: During Surgery
Presence of loco-regional lesions related to the insertion of the trocar (Tolerance of laparoscopy)
Time frame: up to 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing laparotomy and Laparoscopy in people with Preterm Birth and Enterocolitis, Necrotizing, run by Assistance Publique - Hôpitaux de Paris at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Louise MONTALVA, Dr (+33 1.71.73.89.97, louise.montalva@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
C reactive protein blood level (time frame: between Day 0 and Day 2 post surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.