NCT06035848

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
117

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2022

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2022

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

July 4, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 13, 2023

Completed
Last Updated

February 22, 2024

Status Verified

February 1, 2024

Enrollment Period

1.3 years

First QC Date

July 4, 2023

Last Update Submit

February 21, 2024

Conditions

Necrotizing Enterocolitis

Keywords

SurgeryNew bornPediatricsMortality

Outcome Measures

Primary Outcomes (1)

  • 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.

Study Arms (2)

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.

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.

Procedure: Bell's criteria: pneumoperitoneum

Interventions

Association of the components of metabolic derangement and paracentesis.PROCEDURE

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.

Also known as: MD7: components of metabolic derangement
Intervention group
Bell's criteria: pneumoperitoneumPROCEDURE

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.

Control group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de Ginecología y Obstetricia IMIEM

Toluca, 50170, Mexico

Location

Related Publications (1)

  • 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.

    PMID: 41550050DERIVED

MeSH Terms

Conditions

Enterocolitis, Necrotizing

Interventions

Paracentesis

Condition Hierarchy (Ancestors)

EnterocolitisGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisDrainageTherapeuticsPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Gerardo Fernández, MD

    Not affiliated

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
The diagnosis, application of randomization to each group and blood sampling were performed by the neonatology staff, both the patients and the surgical team that provided care were blinded.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Pediatric Surgery Specialty Coordinator / Principal Investigator

Study Record Dates

First Submitted

July 4, 2023

First Posted

September 13, 2023

Study Start

February 1, 2022

Primary Completion

May 31, 2023

Study Completion

June 30, 2023

Last Updated

February 22, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

ME(1)