Clinical trial NCT06035848: Components of Metabolic Derangement and Paracentesis for Determination of Surgery in Preterm Neonates With Necrotizing Enterocolitis.
Official title: Components of Metabolic Derangement and Paracentesis for Determination of Surgery in Preterm Neonates With Necrotizing Enterocolitis.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Necrotizing Enterocolitis
Keywords: Surgery
New born
Pediatrics
Mortality
Lead sponsor: Hospital General de Mexico
Sponsor class: OTHER_GOV
Collaborators: name: Instituto Materno Infantil del Estado de México
name: Instituto de Salud del Estado de México
First posted: 2023-09-13
Enrollment: 117
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* Patients equal to or less than 36.6 weeks gestation, with a diagnosis of NEC stage II A or greater according to Bell criteria.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Mortality in preterm newborns with necrotizing enterocolitis
timeFrame: Neonates were followed from the date of surgery until death or hospital discharge, whichever came first, evaluated up to 6 months.
Secondary outcomes:
Other outcomes:
Locations:
city: Toluca
country: Mexico
facility: Hospital de Ginecología y Obstetricia IMIEM
Study officials:
affiliation: Not affiliated
name: Gerardo Fernández, MD
role: PRINCIPAL_INVESTIGATOR
References: