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

NCT06035848 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 117

Last updated 2024-02-22

No results posted yet for this study

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.

Conditions

  • Necrotizing Enterocolitis

Interventions

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.

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.

Sponsors & Collaborators

  • Instituto Materno Infantil del Estado de México

    collaborator UNKNOWN

  • Instituto de Salud del Estado de México

    collaborator UNKNOWN

  • Gerardo Fernández Ortega

    lead OTHER_GOV

Principal Investigators

  • Gerardo Fernández, MD · Not affiliated

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-01
Primary Completion
2023-05-31
Completion
2023-06-30

Countries

  • Mexico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06035848 on ClinicalTrials.gov