Assessment of Score System to Predict the Need for Surgery in Newborn Infants With Two and More Grades of NEC
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Necrotizing Enterocolitis
- Sponsor
- Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
- Enrollment
- 800
- Locations
- 1
- Primary Endpoint
- accuracy of the score system for predicting the need of surgery
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
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.
Investigators
Chen Long,MD
director
Children's Hospital of Chongqing Medical University
Eligibility Criteria
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
Outcomes
Primary Outcomes
accuracy of the score system for predicting the need of surgery
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: before surgery
positive predictive value of the score system for predicting the need of surgery is assessed