Enteral NutritionNCT05900167
Feeding Intolerance Risk Prediction Model in Patients With Enteral Nutrition Through Nasogastric Tube
An observational study of Enteral Nutrition, run by Xiao Jie Chen.
Trial summary
To explore the risk factors of enteral feeding intolerance in critically ill patients, build a risk prediction model and verify it, in order to provide reference for early identification and screening of high-risk groups Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Enteral Nutrition
- What is being tested?
- enteral nutrition
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 442 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2023to 1 Oct 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The sample size calculation method of this study was based on the results of previous literature studies to obtain enteral nutritional feeding intolerance According to the sample size estimation method of N= [(risk variable) ×(5 ~ 10)] ,the incidence of feeding intolerance was 41.3%,so at least 269 samples are needed for further examination.Considering a 10% loss of follow-up rate, the estimated sample size is 299 cases, the data collected in this part of the study as the model Develop the data set.Using the ratio of modeling group: test group = 7:3, and considering 10% loss of follow-up rate, the minimum sample of test group was 143 cases. Therefore, a total of at least 442 samples are needed in this study.
Who may be able to join
- The nutritional status of the patient is assessed by the doctor and the need for enteral nutrition is determined;Patients with first nasogastric tube insertion and successful enteral feeding;There was no gastrointestinal discomfort before enteral nutrition;Patients (or family members) authorized to participate in this study and signed informed consent
Who cannot join
- Previous gastrointestinal disease or gastrointestinal surgery;enteral nutrition through gastrostomy tube or jejunostomy tube;discontinuation or suspension of enteral nutrition for special reasons other than feeding intolerance;Patients with serious lack of clinical data
About this study
To explore the risk factors of enteral feeding intolerance in critically ill patients, build a risk prediction model and verify it, in order to provide reference for early identification and screening of high-risk groups
Read the detailed description
Based on the previous literature study, the risk factors of enteral feeding intolerance in critically ill patients were obtained, and the general demographic, disease and treatment information of patients were collected. Four machine learning algorithms, namely traditional logistic regression, random forest, support vector machine and naive Bayes, were used to construct risk prediction models, and the optimal model was selected and verified by comparing the model performance
- Conditions
- Enteral Nutrition
- Being tested
- enteral nutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
enteral nutritionBehavioural
The nutritional status of the patient is assessed by the physician to determine the need for enteral nutrition
| Study group | Role | What they receive |
|---|---|---|
| enteral nutrition group | Not described Receives: Behavioral: enteral nutrition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feeding intolerance
Any symptoms of gastrointestinal adverse reactions are defined as feeding intolerance
Measured: Follow-up was considered complete when the patient reached 7 days of enteral nutrition, the patient was transferred from the ICU, or the patient experienced nutritional interruption for other reasons
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2023
- Study start1 Jun 2023 (estimated)
- Primary completion1 Oct 2024 (estimated)
- Study completion1 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Enteral NutritionStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 442 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiao Jie Chen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xiao Jie Chen, RenJi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05900167
- Sponsor's protocol ID
- IIT-2023-0054
- Status last verified
- Jun 2023
- First submitted
- 2 Jun 2023
- Last updated
- 12 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feeding Intolerance Risk Prediction Model in Patients With Enteral Nutrition Through Nasogastric Tube
- ClinicalTrials.gov ID
- NCT05900167
- Acronym / sponsor ID
- IIT-2023-0054
- Conditions
- Enteral Nutrition
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 442 participants (estimated)
- Lead sponsor
- Xiao Jie ChenUniversity, hospital or other
- Study start
- 1 Jun 2023 (estimated)
- Primary completion
- 1 Oct 2024 (estimated)
- Study completion
- 1 Oct 2024 (estimated)
- First posted
- 12 Jun 2023 (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.
To explore the risk factors of enteral feeding intolerance in critically ill patients, build a risk prediction model and verify it, in order to provide reference for early identification and screening of high-risk groups
Detailed description
Based on the previous literature study, the risk factors of enteral feeding intolerance in critically ill patients were obtained, and the general demographic, disease and treatment information of patients were collected. Four machine learning algorithms, namely traditional logistic regression, random forest, support vector machine and naive Bayes, were used to construct risk prediction models, and the optimal model was selected and verified by comparing the model performance
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| enteral nutrition group | – | Behavioral: enteral nutrition |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The sample size calculation method of this study was based on the results of previous literature studies to obtain enteral nutritional feeding intolerance According to the sample size estimation method of N= [(risk variable) ×(5 ~ 10)] ,the incidence of feeding intolerance was 41.3%,so at least 269 samples are needed for further examination.Considering a 10% loss of follow-up rate, the estimated sample size is 299 cases, the data collected in this part of the study as the model Develop the data set.Using the ratio of modeling group: test group = 7:3, and considering 10% loss of follow-up rate, the minimum sample of test group was 143 cases. Therefore, a total of at least 442 samples are needed in this study.
Key inclusion criteria (1 listed)
- The nutritional status of the patient is assessed by the doctor and the need for enteral nutrition is determined;Patients with first nasogastric tube insertion and successful enteral feeding;There was no gastrointestinal discomfort before enteral nutrition;Patients (or family members) authorized to participate in this study and signed informed consent
Key exclusion criteria (1 listed)
- Previous gastrointestinal disease or gastrointestinal surgery;enteral nutrition through gastrostomy tube or jejunostomy tube;discontinuation or suspension of enteral nutrition for special reasons other than feeding intolerance;Patients with serious lack of clinical data
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 |
|---|---|---|
| enteral nutritionThe nutritional status of the patient is assessed by the physician to determine the need for enteral nutrition | Behavioural | enteral nutrition group |
Primary outcome
Feeding intolerance
Time frame: Follow-up was considered complete when the patient reached 7 days of enteral nutrition, the patient was transferred from the ICU, or the patient experienced nutritional interruption for other reasons
Any symptoms of gastrointestinal adverse reactions are defined as feeding intolerance
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2023.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Enteral Nutrition, run by Xiao Jie Chen.
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 1 inclusion and 1 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 12 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feeding intolerance (time frame: Follow-up was considered complete when the patient reached 7 days of enteral nutrition, the patient was transferred from the ICU, or the patient experienced nutritional interruption for other reasons). 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 12 Jun 2023.