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

A

Army Medical University of People's Liberation Army

Status

Enrolling

Conditions

Neonate
Necrotizing Enterocolitis
Surgery

Treatments

Other: score system to predict the need for surgery
Other: usual method to predict the need for surgery

Study type

Observational

Funder types

Other

Identifiers

NCT04795453
NEC surgery

Details and patient eligibility

About

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.

Full 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.

Enrollment

800 estimated patients

Sex

All

Ages

1 hour to 44 weeks old

Volunteers

No Healthy Volunteers

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

Trial design

800 participants in 2 patient 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
Treatment:
Other: usual method to predict the need for surgery
Other: score system to predict the need for surgery
assessment of score system to predict the need for surgery
Description:
two and more grades of NEC is assessed using the score system to predict the need for surgery
Treatment:
Other: usual method to predict the need for surgery
Other: score system to predict the need for surgery

Trial contacts and locations

1

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Central trial contact

Chen Long, MD, PhD

Data sourced from clinicaltrials.gov

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