Status:
TERMINATED
Components of Metabolic Derangement and Paracentesis for Determination of Surgery in Preterm Neonates With Necrotizing Enterocolitis.
Lead Sponsor:
Gerardo Fernández Ortega
Collaborating Sponsors:
Instituto Materno Infantil del Estado de México
Instituto de Salud del Estado de México
Conditions:
Necrotizing Enterocolitis
Eligibility:
All Genders
Phase:
NA
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 questi...
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 gui...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2023
Estimated Enrollment :
117 Patients enrolled
Trial Details
Trial ID
NCT06035848
Start Date
February 1 2022
End Date
June 30 2023
Last Update
February 22 2024
Active Locations (1)
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1
Hospital de Ginecología y Obstetricia IMIEM
Toluca, Mexico, 50170