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

Assessment of Score System to Predict the Need for Surgery in Newborn Infants With Two and More Grades of NEC

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.

Study Overview

• Status: Recruiting
• Conditions: Necrotizing Enterocolitis; Surgery; Neonate
• Intervention / Treatment: Other: score system to predict the need for surgery; Other: usual method to predict the need for 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 Type: Observational
• Enrollment (Anticipated): 800

Contacts and Locations

Study Locations

• China
  • Chongqing
    • Chongqing, Chongqing, China, 400014
      • Recruiting
      • Chen（陈）
      • Contact: Chen（陈） Long, MD,PhD; Phone Number: +8613883559467; Email: neuroclong@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 5 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

two and more of NEC is diagnosed in newborn infants during hospitalization

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
assessment of 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	Other: 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; Other: 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 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	Other: 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; Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
sensitivity of the score system for predicting the need of surgery	sensitivity of the score system for predicting the need of surgery is assessed	before surgery
specificity of the score system for predicting the need of surgery	specificity of the score system for predicting the need of surgery is assessed	before surgery
accuracy of the score system for predicting the need of surgery	accuracy of the score system for predicting the need of surgery is assessed	before surgery
positive likelihood ratio of the score system for predicting the need of surgery	positive likelihood ratio of the score system for predicting the need of surgery is assessed	before surgery
negative likelihood ratio of the score system for predicting the need of surgery	negative likelihood ratio of the score system for predicting the need of surgery is assessed	before surgery
positive predictive value of the score system for predicting the need of surgery	positive predictive value of the score system for predicting the need of surgery is assessed	before surgery
negative predictive value of the score system for predicting the need of surgery	negative predictive value of the score system for predicting the need of surgery is assessed	before surgery

Collaborators and Investigators

• Sponsor: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
• Collaborators: Children's Hospital of Chongqing Medical University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2021
• Primary Completion (Anticipated): December 31, 2024
• Study Completion (Anticipated): December 31, 2024

Study Registration Dates

• First Submitted: March 5, 2021
• First Submitted That Met QC Criteria: March 11, 2021
• First Posted (Actual): March 12, 2021

Study Record Updates

• Last Update Posted (Actual): October 14, 2022
• Last Update Submitted That Met QC Criteria: October 13, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Enterocolitis; Enterocolitis, Necrotizing
• Other Study ID Numbers: NEC surgery

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No