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

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Brief Title

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

Official Title

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

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.
    


Study Type

Observational


Primary Outcome

sensitivity of the score system for predicting the need of surgery


Condition

Necrotizing Enterocolitis

Intervention

score system to predict the need for surgery

Study Arms / Comparison Groups

 assessment of usual method to predict the need for surgery
Description:  two and more grades of NEC is assessed using the usual method to predict the need for surgery

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Other

Estimated Enrollment

800

Start Date

March 1, 2021

Completion Date

December 31, 2024

Primary Completion Date

December 31, 2024

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
      

Gender

All

Ages

N/A - 44 Weeks

Accepts Healthy Volunteers

No

Contacts

, +8613883559467, [email protected]

Location Countries

China

Location Countries

China

Administrative Informations


NCT ID

NCT04795453

Organization ID

NEC surgery


Responsible Party

Principal Investigator

Study Sponsor

Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

Collaborators

 Children's Hospital of Chongqing Medical University

Study Sponsor

, , 


Verification Date

March 2021