Necrotizing EnterocolitisNCT06035848
Components of Metabolic Derangement and Paracentesis for Determination of Surgery in Preterm Neonates With Necrotizing Enterocolitis.
A study testing Association of the components of metabolic derangement and paracentesis. and Bell's criteria: pneumoperitoneum in people with Necrotizing Enterocolitis, run by Gerardo Fernández Ortega at 1 site in Mexico.
Trial summary
The aim of this clinical trial is to associate paracentesis with positive metabolic derangement components for surgical determination in preterm infants with necrotizing enterocolitis. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Necrotizing Enterocolitis
- What is being tested?
- Association of the components of metabolic derangement and paracentesis. and Bell's criteria: pneumoperitoneum
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 117 participants
- Where
- 1 siteMexico
- Study dates
- 1 Feb 2022to 30 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Patients equal to or less than 36.6 weeks gestation, with a diagnosis of NEC stage II A or greater according to Bell criteria.
Who cannot join
- Patients with a history of gastroschisis, suspected Hirschsprung's disease. Patients who do not give authorization for participation.
- Elimination criteria:
- Patients who during follow-up died due to some other condition. Patients who during the study declined to participate. Patients who in the surgical findings had data of Spontaneous Intestinal Perforation.
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this clinical trial is to associate paracentesis with positive metabolic derangement components for surgical determination in preterm infants with necrotizing enterocolitis. The main questions it aims to answer are:
- are the combination of metabolic derangement components and paracentesis good indicators for determining early surgery in preterm patients with necrotizing enterocolitis?
- With the use of the previously mentioned indicators, can mortality in these patients be reduced? Participants will undergo determination of the 7 parameters of the metabolic deterioration components and those with three or more positive points will undergo paracentesis and if this is also positive, it will be determined that the patient requires surgical management.
The researchers will compare with a control group to see the differences in surgical variables (length of necrotic bowel, length of viable bowel, need for intestinal diversion and surgical reintervention) and mortality.
Read the detailed description
Controlled, randomized, double-blind clinical trial approved by the hospital's Ethics and Research Committee, subject to the Declaration of Helsinki. This study follows the CONSORT trial reporting guidelines. Patients younger than 37 weeks of gestation, with NEC stage IIa or greater according to Bell criteria were included.
Two groups of patients were formed (Control and Intervention), randomization was based on a randomization sequence generated using the Graphard 2021 program.
Control group: determination of surgery in a conventional manner according to Bell's criteria (absolute indication: pneumoperitoneum), with radiographic surveillance every 6 hours.
Intervention Group: CMD measurement every 3rd day, it was considered positive when 3 or more points were present. These patients underwent paracentesis and if it was positive (faecal aspiration, serous fluid with Gram + staining, or serohematic fluid) the decision for surgery was made.
Both groups received the same pre- and post-surgical medical management by neonatology.
As a safety criterion, it was defined that when a surgeon considered that a neonate had an indication for surgery, in spite of not meeting the criteria previously indicated for each group, the surgical intervention would be performed.
The diagnosis, implementation of the randomization to each group, and blood sampling were performed by the neonatology staff, the surgical research team being blinded; paracentesis was performed by a pediatric surgeon in the patient's crib with asepsis measures, antisepsis with chlorhexidine, sedation and analgesia (fentanyl 2 to 4 mcg /kg/dose), 1% lidocaine infiltration at the puncture site (iliac fossa right), a 22 G punzocath and a 10 ml syringe were used .
Follow-up was performed until the patient was discharged or died. Mortality was the dependent variable. The time from the patient's admission to the study until surgery was considered; during exploratory laparotomy, the length of intestinal necrosis, length of viable intestine, need for intestinal bypass, surgical intervention performed, and surgical reintervention were determined. In addition, fasting days and parenteral nutrition (TPN) were quantified.
Sample size. Based on the calculation for the difference of two proportions, a size of 31 patients per group was obtained, with a mortality difference of 30%, one-tailed, alpha of 5%, and statistical power of 80%. In June 2022, it was decided to carry out an intermediate analysis to assess the benefit or harm of the intervention, determined by the p value ˂ 0.05 in the dependent variable.
Statistical analysis. Descriptive statistics with measures of central tendency and dispersion were used. For qualitative variables frequencies and percentages, for quantitative variables mean and standard deviation. The Shapiro-Wilk test was used to test normal distribution.
For inferential statistics, group comparisons were performed using the χ2 test, Fisher's exact test, Student's t test or Mann Whitney U test, according to the type and distribution of the variable. The relative risk (RR) was obtained as a measure of association, with 95% confidence interval (CI). In addition, a bivariate analysis was performed between mortality and secondary variables. Statistical significance was established with a p-value <0.05.
- Conditions
- Necrotizing Enterocolitis
- Being tested
- Association of the components of metabolic derangement and paracentesis., Bell's criteria: pneumoperitoneum
- Keywords
- Surgery, New born, Pediatrics, Mortality
- Medical subject headings
- Enterocolitis, Necrotizing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Association of the components of metabolic derangement and paracentesis.Procedure or surgery
Also called MD7: components of metabolic derangement
In the intervention group were determined:
- Components of metabolic derangement
- Paracentesis. Determination of surgery: 3 positive points of the components of the metabolic derangement and a positive paracentesis.
The components of the metabolic derangement are the 7 parameters described by Tepas: positive blood culture, metabolic acidosis, neutropenia, bandemia, thrombocytopenia, hyponatremia and hypotension, being considered positive when 3 or more parameters are present.
Paracentesis was considered positive according to Kosloske's criteria: obtaining more than 0.5ml of serohematic fluid, Gram-positive fluid and obtaining fecal material.
Both groups had the same pre, trans and postoperative care.
Bell's criteria: pneumoperitoneumProcedure or surgery
In the control group, the surgery was determined according to Bell's criteria, in the presence of radiographic pneumoperitoneum as an absolute indication for surgery.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Components of metabolic derangement measurement every 3rd day, it was considered positive when 3 or more points were present. These patients underwent paracentesis and if it was positive (faecal aspiration, serous fluid with Gram + staining, or serohematic fluid) the decision for surgery was made. Receives: Procedure: Association of the components of metabolic derangement and paracentesis. |
| Control group | Active comparator | Determination of surgery in a conventional manner according to Bell's criteria (absolute indication: pneumoperitoneum), with radiographic surveillance every 6 hours. Receives: Procedure: Bell's criteria: pneumoperitoneum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality in preterm newborns with necrotizing enterocolitis
The mortality of patients with necrotizing enterocolitis who required surgical management in both groups was determined.
Measured: Neonates were followed from the date of surgery until death or hospital discharge, whichever came first, evaluated up to 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2023
- Study start1 Feb 2022
- Primary completion31 May 2023
- Study completion30 Jun 2023
Why it stopped: In June 2023, it was decided to perform an intermediate analysis to assess the benefit or harm of the intervention.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Necrotizing EnterocolitisStudies of the same condition, open and under way.
- 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
- The aim of this study was to determine an indication for early surgery in preterm neonates with necrotizing enterocolitis by using paracentesis in combination with the components of metabolic derangement compared to using the Bell´s criteria. Two groups of patients were formed (Control and Intervention). Control group: determination of surgery in a conventional manner according to Bell's criteria (absolute indication: pneumoperitoneum), with radiographic surveillance every 6 hours. Intervention Group: components of metabolic derangement measurement every 3rd day, it was considered positive when 3 or more points were present. These patients underwent paracentesis and if it was positive (faecal aspiration, serous fluid with Gram + staining, or serohematic fluid) the decision for surgery was made.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gerardo Fernández Ortega
- Sponsor type
- Other government
- Collaborators
- Instituto Materno Infantil del Estado de México, Instituto de Salud del Estado de México
- Responsible party
- Sponsor-investigator, Gerardo Fernández Ortega, Hospital General de Mexico
- Investigators
- Gerardo Fernández, MD, Principal investigator, Not affiliated
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06035848
- Sponsor's protocol ID
- 01-2021
- Status last verified
- Feb 2024
- First submitted
- 4 Jul 2023
- Last updated
- 22 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fernandez Ortega G, Martin De Saro MD, Cuevas Covarrubias SA, Moron Garcia GC, Plaza Benhumea L. Surgical decision-making strategies in preterm neonates with necrotizing enterocolitis: A randomized controlled clinical trial. Cir Pediatr. 2026 Jan 15;39(1):15-21. doi: 10.54847/cp.2026.01.13. English, Spanish.
PubMed 41550050
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Components of Metabolic Derangement and Paracentesis for Determination of Surgery in Preterm Neonates With Necrotizing Enterocolitis.
- ClinicalTrials.gov ID
- NCT06035848
- Acronym / sponsor ID
- 01-2021
- Conditions
- Necrotizing Enterocolitis
- Keywords
- Surgery, New born, Pediatrics, Mortality
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: In June 2023, it was decided to perform an intermediate analysis to assess the benefit or harm of the intervention.
- Enrolment
- 117 participants (actual)
- Lead sponsor
- Gerardo Fernández OrtegaOther government
- Collaborators
- Instituto Materno Infantil del Estado de México, Instituto de Salud del Estado de México
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 31 May 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 13 Sep 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.
The aim of this clinical trial is to associate paracentesis with positive metabolic derangement components for surgical determination in preterm infants with necrotizing enterocolitis. The main questions it aims to answer are:
- are the combination of metabolic derangement components and paracentesis good indicators for determining early surgery in preterm patients with necrotizing enterocolitis?
- With the use of the previously mentioned indicators, can mortality in these patients be reduced? Participants will undergo determination of the 7 parameters of the metabolic deterioration components and those with three or more positive points will undergo paracentesis and if this is also positive, it will be determined that the patient requires surgical management.
The researchers will compare with a control group to see the differences in surgical variables (length of necrotic bowel, length of viable bowel, need for intestinal diversion and surgical reintervention) and mortality.
Detailed description
Controlled, randomized, double-blind clinical trial approved by the hospital's Ethics and Research Committee, subject to the Declaration of Helsinki. This study follows the CONSORT trial reporting guidelines. Patients younger than 37 weeks of gestation, with NEC stage IIa or greater according to Bell criteria were included.
Two groups of patients were formed (Control and Intervention), randomization was based on a randomization sequence generated using the Graphard 2021 program.
Control group: determination of surgery in a conventional manner according to Bell's criteria (absolute indication: pneumoperitoneum), with radiographic surveillance every 6 hours.
Intervention Group: CMD measurement every 3rd day, it was considered positive when 3 or more points were present. These patients underwent paracentesis and if it was positive (faecal aspiration, serous fluid with Gram + staining, or serohematic fluid) the decision for surgery was made.
Both groups received the same pre- and post-surgical medical management by neonatology.
As a safety criterion, it was defined that when a surgeon considered that a neonate had an indication for surgery, in spite of not meeting the criteria previously indicated for each group, the surgical intervention would be performed.
The diagnosis, implementation of the randomization to each group, and blood sampling were performed by the neonatology staff, the surgical research team being blinded; paracentesis was performed by a pediatric surgeon in the patient's crib with asepsis measures, antisepsis with chlorhexidine, sedation and analgesia (fentanyl 2 to 4 mcg /kg/dose), 1% lidocaine infiltration at the puncture site (iliac fossa right), a 22 G punzocath and a 10 ml syringe were used .
Follow-up was performed until the patient was discharged or died. Mortality was the dependent variable. The time from the patient's admission to the study until surgery was considered; during exploratory laparotomy, the length of intestinal necrosis, length of viable intestine, need for intestinal bypass, surgical intervention performed, and surgical reintervention were determined. In addition, fasting days and parenteral nutrition (TPN) were quantified.
Sample size. Based on the calculation for the difference of two proportions, a size of 31 patients per group was obtained, with a mortality difference of 30%, one-tailed, alpha of 5%, and statistical power of 80%. In June 2022, it was decided to carry out an intermediate analysis to assess the benefit or harm of the intervention, determined by the p value ˂ 0.05 in the dependent variable.
Statistical analysis. Descriptive statistics with measures of central tendency and dispersion were used. For qualitative variables frequencies and percentages, for quantitative variables mean and standard deviation. The Shapiro-Wilk test was used to test normal distribution.
For inferential statistics, group comparisons were performed using the χ2 test, Fisher's exact test, Student's t test or Mann Whitney U test, according to the type and distribution of the variable. The relative risk (RR) was obtained as a measure of association, with 95% confidence interval (CI). In addition, a bivariate analysis was performed between mortality and secondary variables. Statistical significance was established with a p-value <0.05.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- The aim of this study was to determine an indication for early surgery in preterm neonates with necrotizing enterocolitis by using paracentesis in combination with the components of metabolic derangement compared to using the Bell´s criteria. Two groups of patients were formed (Control and Intervention). Control group: determination of surgery in a conventional manner according to Bell's criteria (absolute indication: pneumoperitoneum), with radiographic surveillance every 6 hours. Intervention Group: components of metabolic derangement measurement every 3rd day, it was considered positive when 3 or more points were present. These patients underwent paracentesis and if it was positive (faecal aspiration, serous fluid with Gram + staining, or serohematic fluid) the decision for surgery was made.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Procedure: Association of the components of metabolic derangement and paracentesis.Components of metabolic derangement measurement every 3rd day, it was considered positive when 3 or more points were present. These patients underwent paracentesis and if it was positive (faecal aspiration, serous fluid with Gram + staining, or serohematic fluid) the decision for surgery was made. |
| Control group | Active comparator | Procedure: Bell's criteria: pneumoperitoneumDetermination of surgery in a conventional manner according to Bell's criteria (absolute indication: pneumoperitoneum), with radiographic surveillance every 6 hours. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients equal to or less than 36.6 weeks gestation, with a diagnosis of NEC stage II A or greater according to Bell criteria.
Key exclusion criteria (3 listed)
- Patients with a history of gastroschisis, suspected Hirschsprung's disease. Patients who do not give authorization for participation.
- Patients who during follow-up died due to some other condition. Patients who during the study declined to participate. Patients who in the surgical findings had data of Spontaneous Intestinal Perforation.
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 |
|---|---|---|
| Association of the components of metabolic derangement and paracentesis.Also: MD7: components of metabolic derangementIn the intervention group were determined: 1. Components of metabolic derangement 2. Paracentesis. Determination of surgery: 3 positive points of the components of the metabolic derangement and a positive paracentesis. The components of the metabolic derangement are the 7 parameters described by Tepas: positive blood culture, metabolic acidosis, neutropenia, bandemia, thrombocytopenia, hyponatremia and hypotension, being considered positive when 3 or more parameters are present. Paracentesis was considered positive according to Kosloske's criteria: obtaining more than 0.5ml of serohematic fluid, Gram-positive fluid and obtaining fecal material. Both groups had the same pre, trans and postoperative care. | Procedure or surgery | Intervention group |
| Bell's criteria: pneumoperitoneumIn the control group, the surgery was determined according to Bell's criteria, in the presence of radiographic pneumoperitoneum as an absolute indication for surgery. | Procedure or surgery | Control group |
Primary outcome
Mortality in preterm newborns with necrotizing enterocolitis
Time frame: Neonates were followed from the date of surgery until death or hospital discharge, whichever came first, evaluated up to 6 months.
The mortality of patients with necrotizing enterocolitis who required surgical management in both groups was determined.
Results and safety
The study was stopped early (reason given: In June 2023, it was decided to perform an intermediate analysis to assess the benefit or harm of the intervention.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2024.
- Derived from this study: PubMed 41550050Fernandez Ortega G, Martin De Saro MD, Cuevas Covarrubias SA, Moron Garcia GC, Plaza Benhumea L. Surgical decision-making strategies in preterm neonates with necrotizing enterocolitis: A randomized controlled clinical trial. Cir Pediatr. 2026 Jan 15;39(1):15-21. doi: 10.54847/cp.2026.01.13. English, Spanish.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Gerardo Fernández, MD principal investigator
Not affiliated
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Association of the components of metabolic derangement and paracentesis. and Bell's criteria: pneumoperitoneum in people with Necrotizing Enterocolitis, run by Gerardo Fernández Ortega at 1 site in Mexico.
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 1 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: stopped early, as of the sponsor's last update on 22 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. 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?
The study was stopped early (reason given: In June 2023, it was decided to perform an intermediate analysis to assess the benefit or harm of the intervention.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality in preterm newborns with necrotizing enterocolitis (time frame: Neonates were followed from the date of surgery until death or hospital discharge, whichever came first, evaluated up to 6 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06035848, which also lists 1 linked publication.
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 22 Feb 2024.