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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04795453
Enrollment
800
Registered
2021-03-12
Start date
2021-03-01
Completion date
2024-12-31
Last updated
2022-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Necrotizing Enterocolitis, Neonate, Surgery

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.

Interventions

OTHERscore 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

OTHERusual 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

Sponsors

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

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
1 Hours to 44 Weeks
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
sensitivity of the score system for predicting the need of surgerybefore surgerysensitivity of the score system for predicting the need of surgery is assessed
specificity of the score system for predicting the need of surgerybefore surgeryspecificity of the score system for predicting the need of surgery is assessed
accuracy of the score system for predicting the need of surgerybefore surgeryaccuracy of the score system for predicting the need of surgery is assessed
positive likelihood ratio of the score system for predicting the need of surgerybefore surgerypositive likelihood ratio of the score system for predicting the need of surgery is assessed
negative likelihood ratio of the score system for predicting the need of surgerybefore surgerynegative 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 surgerybefore surgerypositive predictive value of the score system for predicting the need of surgery is assessed
negative predictive value of the score system for predicting the need of surgerybefore surgerynegative predictive value of the score system for predicting the need of surgery is assessed

Countries

China

Contacts

Primary ContactChen Long, MD, PhD
neuroclong@126.com+8613883559467

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026