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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Necrotizing Enterocolitis, Neonate, Surgery

Intervention / Treatment
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* Other: score system to predict the need for surgery
* Other: usual method to predict the need for surgery


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Hour
Maximum Age: 44 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| assessment of usual method to predict the need for surgery<br>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<br>* two and more grades of NEC is assessed using the score system to predict the need for surgery<br>Other: usual method to predict the need for surgery<br>* two and more grades of NEC is assessed using the usual method to predict the need for surgery<br>|
| assessment of score system to predict the need for surgery<br>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<br>* two and more grades of NEC is assessed using the score system to predict the need for surgery<br>Other: usual method to predict the need for surgery<br>* two and more grades of NEC is assessed using the usual method to predict the need for surgery<br>|

What is the study measuring?
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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 |