Assessment of Score System of Surgery in Necrotizing Enterocolitis(NEC) Patients

Recruiting

• Conditions: Neonate; Surgery; Necrotizing Enterocolitis
• Interventions: Other: score system to predict the need for surgery; Other: usual method to predict the need for surgery

• Registration Number: NCT04795453
• Lead Sponsor: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

Brief Summary

Necrotizing enterocolitis(NEC) is one of the most serious disease in the newborn infants, and two and more grades of NEC usually lead to surgery, even death. But, it is difficult to predict when to operate the surgery.

Detailed Description

Necrotizing enterocolitis(NEC) is characterized by vomit, abdominal distention, hypoactive bowel sounds and bloody stools, even shock, disseminated intravascular coagulation(DIC) and sepsis. X-ray is shown Intestinal wall gas and/or portal vein pneumatosis and pneumoperitoneum.

Two and more grades of NEC in newborn infant is a urgent condition, and whether or not operation is difficult to predict.

Here, the investigators develop a score system including five parameters(abdominal circumference, base excess, heart rate, severities of respiratory distress, sepsis) in one retrospective cohort, and the score system is used and assessed to predict the need for surgery in another prospective cohort.

Study Timeline

• Study Start: 2021-03-01
• Study First Submitted: 2021-03-05
• Study First Submitted QC: 2021-03-11
• Study First Posted: 2021-03-12
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-13
• Last Update Posted: 2022-10-14
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 800

Inclusion Criteria

• two and more of NEC is diagnosed in the newborn infants
• on the time of diagnosis for NEC both the surgery and non-surgery are reasonable according the surgeon's suggestions

Exclusion Criteria

• pneumoperitoneum
• refusing to take part in the study according to parents' decision

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
assessment of score system to predict the need for surgery	score system to predict the need for surgery	two and more grades of NEC is assessed using the score system to predict the need for surgery
assessment of score system to predict the need for surgery	usual method to predict the need for surgery	two and more grades of NEC is assessed using the score system to predict the need for surgery
assessment of usual method to predict the need for surgery	usual method to predict the need for surgery	two and more grades of NEC is assessed using the usual method to predict the need for surgery
assessment of usual method to predict the need for surgery	score system to predict the need for surgery	two and more grades of NEC is assessed using the usual method to predict the need for surgery

Primary Outcome Measures

Name	Time	Method
accuracy of the score system for predicting the need of surgery	before surgery	accuracy of the score system for predicting the need of surgery is assessed
negative predictive value of the score system for predicting the need of surgery	before surgery	negative predictive value of the score system for predicting the need of surgery is assessed
positive likelihood ratio of the score system for predicting the need of surgery	before surgery	positive likelihood ratio of the score system for predicting the need of surgery is assessed
sensitivity of the score system for predicting the need of surgery	before surgery	sensitivity of the score system for predicting the need of surgery is assessed
specificity of the score system for predicting the need of surgery	before surgery	specificity of the score system for predicting the need of surgery is assessed
negative likelihood ratio of the score system for predicting the need of surgery	before surgery	negative likelihood ratio of the score system for predicting the need of surgery is assessed
positive predictive value of the score system for predicting the need of surgery	before surgery	positive predictive value of the score system for predicting the need of surgery is assessed

Trial Locations

Locations (1)

Chen（陈）; 🇨🇳 Chongqing, Chongqing, China