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Status unknownNCT04795453Updated Oct 14, 2022

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

An observational study in Necrotizing Enterocolitis, Neonate and Surgery, sponsored by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University. Status unknown at 1 site in China. Open to participants aged 1 Hour to 44 Weeks. Per ClinicalTrials.gov, last updated 2022-10-14.

Sponsored by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University · Observational

The sponsor has not verified this record recently (last verified Oct 2022), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
800
Ages
1 Hour to 44 Weeks
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Necrotizing Enterocolitis
  • Neonate
  • Surgery
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In context

Enterocolitis

216 studies on the registry are indexed under Enterocolitis; 26 are open to participants now.

This study's planned enrollment of 800 is above the median of 78 across 86 observational studies indexed under Enterocolitis.

Browse Enterocolitis studies →

Lead sponsor

Daping Hospital and the Research Institute of Surgery of the Third Military Medical University is the lead sponsor of 115 studies on the registry; 41 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
1 Hour to 44 Weeks
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

two and more of NEC is diagnosed in newborn infants during hospitalization

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

Exclusion Criteria:

  • pneumoperitoneum
  • refusing to take part in the study according to parents' decision
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
800 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

    Other: score system to predict the need for surgery · Other: 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

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

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

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What researchers measure

Primary outcomes

  1. sensitivity of the score system for predicting the need of surgery

    sensitivity of the score system for predicting the need of surgery is assessed

    Time frame: before surgery

  2. specificity of the score system for predicting the need of surgery

    specificity of the score system for predicting the need of surgery is assessed

    Time frame: before surgery

  3. accuracy of the score system for predicting the need of surgery

    accuracy of the score system for predicting the need of surgery is assessed

    Time frame: before surgery

  4. positive likelihood ratio of the score system for predicting the need of surgery

    positive likelihood ratio of the score system for predicting the need of surgery is assessed

    Time frame: before surgery

  5. negative likelihood ratio of the score system for predicting the need of surgery

    negative likelihood ratio of the score system for predicting the need of surgery is assessed

    Time frame: before surgery

  6. positive predictive value of the score system for predicting the need of surgery

    positive predictive value of the score system for predicting the need of surgery is assessed

    Time frame: before surgery

  7. negative predictive value of the score system for predicting the need of surgery

    negative predictive value of the score system for predicting the need of surgery is assessed

    Time frame: before surgery

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Study locations

1 of 1 sites recruiting
  • Chen(陈)
    Chongqing, Chongqing 400014, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 14, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04795453
Lead sponsor
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Collaborators
Children's Hospital of Chongqing Medical University
Responsible party
Chen Long,MD (director, Children's Hospital of Chongqing Medical University) — Principal investigator
First posted
Mar 12, 2021
Start date
Mar 1, 2021
Primary completion
Dec 31, 2024 (estimated)
Completion
Dec 31, 2024 (estimated)
Last update
Oct 14, 2022

Study contacts

Chen Long, MD, PhD
Contact
neuroclong@126.com
+8613883559467

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.

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