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

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04795453
• Other study ID #: NEC surgery
• Status: Recruiting
• Start date: March 1, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: October 2022
• Source: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
• Contact: Chen Long, MD, PhD
• Phone: +8613883559467
• Email: neuroclong[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 800
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Hour to 44 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Enterocolitis
• Enterocolitis, Necrotizing
• Necrotizing Enterocolitis
• Neonate
• Surgery

Intervention

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
• 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

Locations

Country	Name	City	State
China	Chen(?)	Chongqing	Chongqing

Sponsors (2)

Lead Sponsor	Collaborator
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University	Children's Hospital of Chongqing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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