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

February 21, 2024 updated by: Gerardo Fernández Ortega

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

117

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
      • Toluca, Mexico, 50170
        • Hospital de Ginecología y Obstetricia IMIEM

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Procedure: Association of the components of metabolic derangement and paracentesis.

In 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.

Other Names:
  • MD7: components of metabolic derangement
Active Comparator: Control group
Determination of surgery in a conventional manner according to Bell's criteria (absolute indication: pneumoperitoneum), with radiographic surveillance every 6 hours.
Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Neonates were followed from the date of surgery until death or hospital discharge, whichever came first, evaluated up to 6 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gerardo Fernández Ortega

Collaborators

Instituto de Salud del Estado de México
Instituto Materno Infantil del Estado de México

Investigators

  • Principal Investigator: Gerardo Fernández, MD, Not affiliated

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2022

Primary Completion (Actual)

May 31, 2023

Study Completion (Actual)

June 30, 2023

Study Registration Dates

First Submitted

July 4, 2023

First Submitted That Met QC Criteria

September 6, 2023

First Posted (Actual)

September 13, 2023

Study Record Updates

Last Update Posted (Estimated)

February 22, 2024

Last Update Submitted That Met QC Criteria

February 21, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 01-2021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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