Necrotizing EnterocolitisNCT04795453
Assessment of Score System of Surgery in Necrotizing Enterocolitis(NEC) Patients
An observational study of Necrotizing Enterocolitis and Neonate, run by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University at 1 site in China.
Trial 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 more about this study
- Who is it for?
- Ages 1 hour to 44 weeks
- Conditions the study is for
- Necrotizing Enterocolitis, Neonate, Surgery
- What is being tested?
- score system to predict the need for surgery and usual method to predict the need for surgery
- How many people
- 800 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2021to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 hour to 44 weeks
- All sexes
- No healthy volunteers
- Child
Study population: two and more of NEC is diagnosed in newborn infants during hospitalization
Who may be able to join
- 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
Who cannot join
- pneumoperitoneum
- refusing to take part in the study according to parents' decision
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Chen（陈）
Chongqing, Chongqing Municipality, 400014
Chen（陈） Long, MD,PhD, +8613883559467, neuroclong@126.com
About this study
Official title: Assessment of Score System to Predict the Need for Surgery in Newborn Infants With Two and More Grades of NEC
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.
- Conditions
- Necrotizing Enterocolitis, Neonate, Surgery
- Being tested
- score system to predict the need for surgery, usual method to predict the need for surgery
- Medical subject headings
- Enterocolitis, Necrotizing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
score system to predict the need for surgeryOther
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 surgeryOther
two and more grades of NEC is assessed using the usual method to predict the need for surgery
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: score system to predict the need for surgery; Other: usual method to predict the need for surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
sensitivity of the score system for predicting the need of surgery
sensitivity of the score system for predicting the need of surgery is assessed
Measured: before surgery
specificity of the score system for predicting the need of surgery
specificity of the score system for predicting the need of surgery is assessed
Measured: before surgery
accuracy of the score system for predicting the need of surgery
accuracy of the score system for predicting the need of surgery is assessed
Measured: before surgery
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
Measured: before surgery
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
Measured: before surgery
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
Measured: before surgery
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
Measured: before surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2021
- Study start1 Mar 2021
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Necrotizing EnterocolitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Hospital of Chongqing Medical University
- Responsible party
- Principal investigator, Chen Long,MD, Children's Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04795453
- Sponsor's protocol ID
- NEC surgery
- Status last verified
- Oct 2022
- First submitted
- 5 Mar 2021
- Last updated
- 14 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Score System to Predict the Need for Surgery in Newborn Infants With Two and More Grades of NEC
- ClinicalTrials.gov ID
- NCT04795453
- Acronym / sponsor ID
- NEC surgery
- Conditions
- Necrotizing Enterocolitis, Neonate, Surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Daping Hospital and the Research Institute of Surgery of the Third Military Medical UniversityUniversity, hospital or other
- Collaborators
- Children's Hospital of Chongqing Medical University
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 12 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| assessment of 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 surgerytwo 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 | – | Other: score system to predict the need for surgery, Other: usual method to predict the need for surgerytwo and more grades of NEC is assessed using the score system to predict the need for surgery |
Who may qualify
- Ages
- 1 hour to 44 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- two and more of NEC is diagnosed in newborn infants during hospitalization
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- pneumoperitoneum
- refusing to take part in the study according to parents' decision
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| score system to predict the need for surgerytwo and more grades of NEC is assessed using the score system to predict the need for surgery | Other | assessment of score system to predict the need for surgery, assessment of usual method to predict the need for surgery |
| usual method to predict the need for surgerytwo and more grades of NEC is assessed using the usual method to predict the need for surgery | Other | assessment of score system to predict the need for surgery, assessment of usual method to predict the need for surgery |
Primary outcome
sensitivity of the score system for predicting the need of surgery
Time frame: before surgery
sensitivity of the score system for predicting the need of surgery is assessed
specificity of the score system for predicting the need of surgery
Time frame: before surgery
specificity of the score system for predicting the need of surgery is assessed
accuracy of the score system for predicting the need of surgery
Time frame: before surgery
accuracy of the score system for predicting the need of surgery is assessed
positive likelihood ratio of the score system for predicting the need of surgery
Time frame: before surgery
positive 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 surgery
Time frame: before surgery
negative 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 surgery
Time frame: before surgery
positive 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 surgery
Time frame: before surgery
negative predictive value of the score system for predicting the need of surgery is assessed
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2022.
Related trials for Necrotizing Enterocolitis
Recruiting
Study of the Influence of Intraperitoneal Insufflation of CO2 by Laparoscopy on the Short-term Evolution of Premature Infants With Ulcerative Necrotizing Enterocolitis
Preterm Birth, Enterocolitis, Necrotizing
RecruitingObservational study
Multidimensional Dynamic Early Warning System for Neonatal Necrotizing Enterocolitis: A Multicenter Clinical Study
NEC - Necrotizing Enterocolitis
Recruiting
Fecal Microbiota Transplantation (FMT) as a Prophylaxis of Necrotizing Enterocolitis (NEC) - Clinical Study
Necrotizing Enterocolitis (NEC), Necrotizing Enterocolitis of Newborn
Active, not recruitingObservational study
Early Predictors of Necrotizing Enterocolitis in Neonates
Necrotizing Enterocolitis
Recruiting
Effects of Enteral Feeding Regimens on NEC, Mortality, and Neurodevelopment in Very Preterm Infants
Very Preterm Infant, Necrotizing Enterocolitis (NEC)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Necrotizing Enterocolitis and Neonate, run by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chen Long, MD, PhD (+8613883559467, neuroclong@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sensitivity of the score system for predicting the need of surgery (time frame: before surgery). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2022.