NCT04795453

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 800 (estimated)
• Sponsor: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University · Academic / Other
• Sex: All
• Age: 1 Hour – 44 Weeks
• Healthy volunteers: Not accepted

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.

Conditions

• Necrotizing Enterocolitis
• Neonate
• Surgery

Interventions

Type	Name	Description
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

Timeline

• Start date: 2021-03-01
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2021-03-12
• Last updated: 2022-10-14

Locations

1 site across 1 country: China