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

NCT ID: NCT04795453

Last Updated: 2022-10-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

800 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-03-01

Study Completion Date

2024-12-31

Brief Summary

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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

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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

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Necrotizing Enterocolitis Neonate Surgery

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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assessment of 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

score system to predict the need for surgery

Intervention Type OTHER

two and more grades of NEC is assessed using the score system to predict the need for surgery

usual method to predict the need for surgery

Intervention Type OTHER

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

assessment of 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

score system to predict the need for surgery

Intervention Type OTHER

two and more grades of NEC is assessed using the score system to predict the need for surgery

usual method to predict the need for surgery

Intervention Type OTHER

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

Interventions

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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

Intervention Type 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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

1 Hour

Maximum Eligible Age

44 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Children's Hospital of Chongqing Medical University

OTHER

Sponsor Role collaborator

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

OTHER

Sponsor Role lead

Responsible Party

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Chen Long,MD

director

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Chen(陈)

Chongqing, Chongqing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Chen Long, MD, PhD

Role: CONTACT

+8613883559467

Facility Contacts

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Chen(陈) Long, MD,PhD

Role: primary

+8613883559467

Other Identifiers

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NEC surgery

Identifier Type: -

Identifier Source: org_study_id

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