Components of Metabolic Derangement and Paracentesis for Determination of Surgery in Preterm Neonates With Necrotizing Enterocolitis.

Necrotizing Enterocolitis Clinical Trial

Official title:

Components of Metabolic Derangement and Paracentesis for Determination of Surgery in Preterm Neonates With Necrotizing Enterocolitis.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT06035848
• Other study ID #: 01-2021
• Status: Terminated
• Phase: N/A
• Start date: February 1, 2022
• Est. completion date: June 30, 2023

Study information

• Verified date: February 2024
• Source: Hospital General de Mexico
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 117
• Est. completion date: June 30, 2023
• Est. primary completion date: May 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Enterocolitis
• Enterocolitis, Necrotizing
• Metabolic Diseases
• Necrotizing Enterocolitis

Intervention

Procedure:
• Association of the components of metabolic derangement and paracentesis.
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: pneumoperitoneum
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.

Locations

Country	Name	City	State
Mexico	Hospital de Ginecología y Obstetricia IMIEM	Toluca

Sponsors (3)

Lead Sponsor	Collaborator
Gerardo Fernández Ortega	Instituto de Salud del Estado de México, Instituto Materno Infantil del Estado de México

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality in preterm newborns with necrotizing enterocolitis	The mortality of patients with necrotizing enterocolitis who required surgical management in both groups was determined.	Neonates were followed from the date of surgery until death or hospital discharge, whichever came first, evaluated up to 6 months.