Hospitalized ChildrenNCT07038538
Evidence-based Practice in the Management of Gastric Tube Placement in Children
A study testing Evidence-based gastric placement in people with Hospitalized Children and Nursing, run by Children's Hospital of Fudan University at 22 sites in China.
Trial summary
This multi-center quality improvement project aims to enhance gastric tube placement practices for children by systematically reviewing the latest evidence. The project team will identify gaps between current practices and best evidence, analyze barriers to implementing evidence-based guidelines, and develop… Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Hospitalized Children, Nursing, Enteral Nutrition Therapy
- What is being tested?
- Evidence-based gastric placement
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,750 participants
- Where
- 22 sitesChina
- Study dates
- 26 Jun 2025to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Nurses who hold a valid and legal nursing license.
- Nurses who have at least 1 year of clinical nursing experience in pediatric care.
- Hospitalized children Aged 0-18 years.
- Scheduled for nasogastric tube placement.
- Parents or legal guardians have signed the informed consent form, agreeing to the child's participation in the study.
Who cannot join
- Nurses who are on leave or not on duty.
- Nurses working in departments such as the operating room or intravenous compounding center, where nasogastric tube placement is not routinely performed.
- Nurses who are in training or on internships.
- Pediatric Patient Inclusion and Exclusion Criteria:
- Presence of severe complications or unstable medical conditions.
- Nasogastric tube is intended for gastrointestinal decompression, drainage, or venting.
Trial locations and contacts
22 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Yuyan Huang contact
22 sites in 1 country
China22 sites, 22 recruiting
- Recruiting
Beijing Children's Hospital, Capital Medical University
Beijing
Wei Chi
- Recruiting
Capital Center for Children's Health,Capital Medical University
Beijing
Lili Liu
- Recruiting
Peking University First Hospital
Beijing
Jingwen Meng
- Recruiting
Children's Hospital of Chongqing Medical University
Chongqing
Cui Cui
- Recruiting
Gansu Provincial Maternity and Child-care Hospital/Gansu Provincial Central Hospital
Gansu
Ping Liu
- Recruiting
Guangzhou Women and Children's Medical Center
Guangdong
Yan Lin
- Recruiting
Anhui Provincial Children's Hospital
Hefei
Hongqin Wang
- Recruiting
Henan Provincial People's Hospital
Henan
Caixiao Shi
- Recruiting
Hunan Children's Hospital
Hunan
Jianhui Xie
- Recruiting
The First Hospital of Jilin University
Jilin City
Baorong Zhang
- Recruiting
Jinan Maternity and Child Health Care Hospital
Jinan
Zhaofang Zhang
- Recruiting
Kunming Children's Hospital
Kunming
Yuting Zheng
- Recruiting
Children's Hospital of Nanjing Medical University
Nanjing
Mingqi Peng
- Recruiting
Qingdao Women and Children's Hospital
Qingdao
Lu Mei
- Recruiting
Children's Hospital of Fudan University
Shanghai, Minhang, 201102
Ying Gu, Doctor, +86 13816881726, guying_gy@fudan.edu.cn
- Recruiting
Shengjing Hospital of China Medical University
Shenyang
Xinlin He
- Recruiting
Shenzhen Children's Hospital
Shenzhen
Zhitian Xiao
- Recruiting
West China Second University Hospital, Sichuan University
Sichuan
Xiufang Zhao
- Recruiting
Children's Hospital of Soochow University
Suzhou
Wenying Yao
- Recruiting
The First People's Hospital of Urumqi （Urumqi Children's Hospital)
Ürümqi
Peng Liu
- Recruiting
Tongji Hospital,Tongji Medical College of HUST
Wuhan
Genzhen Yu
- Recruiting
Children's hospital,Zhejiang University School of Medicine
Zhejiang
Yaping Ding
About this study
Official title: Evidence-based Practice in the Management of Gastric Tube Placement in Children: A Multicenter Quality Improvement Project
This multi-center quality improvement project aims to enhance gastric tube placement practices for children by systematically reviewing the latest evidence. The project team will identify gaps between current practices and best evidence, analyze barriers to implementing evidence-based guidelines, and develop strategies to facilitate their integration into clinical settings. The focus will also be on improving the knowledge and skills of pediatric nurses through targeted education and support. Ultimately, this initiative seeks to ensure the safety and effectiveness of gastric tube placement in the pediatric population, leading to better patient outcomes and higher standards of care.
Read the detailed description
Enteral nutrition is the preferred method of nutritional support for children with gastrointestinal function, encompassing both oral and tube feeding approaches. Tube feeding involves delivering liquid food, water, and medications directly into the gastrointestinal tract through a feeding tube, making it a primary method of enteral nutrition. Compared to parenteral nutrition, enteral nutrition is more aligned with the body's physiological needs, helping to maintain the intestinal mucosal barrier, protect organ function, and regulate immune responses while being easier to initiate, cost-effective, and associated with a lower risk of infection.
In 2009, the American Society for Parenteral and Enteral Nutrition (ASPEN) published guidelines for enteral nutrition practices, which were updated in 2017. ASPEN also launched the Verification of Enteral Tube Location Project (NOVEL) in 2019, providing clear protocols for the placement of nasogastric tubes in children. Additionally, the European Society for Pediatric Gastroenterology, Hepatology, and Nutrition issued a position statement on nasoenteric feeding for children in 2019.
In China, pediatric clinical nutrition has developed more slowly, but pediatric tube feeding has received growing attention in recent years. The Chinese Society of Parenteral and Enteral Nutrition published clinical application guidelines for pediatric enteral and parenteral nutrition support in 2010, followed by neonatal nutrition support guidelines in 2013. However, there have been no recent updates or standardized procedures for pediatric tube feeding.
This study aims to synthesize the latest evidence on pediatric gastric tube placement and update healthcare professionals' knowledge in pediatric medical institutions, which also seeks to standardize tube placement techniques and apply best practices in clinical settings to enhance the safety and quality of care for children.
- Conditions
- Hospitalized Children, Nursing, Enteral Nutrition Therapy
- Being tested
- Evidence-based gastric placement
- Keywords
- Quality Improvement, Before-and-After Comparison, Cognitive and behavior
- Medical subject headings
- Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evidence-based gastric placementBehavioural
Establish an enteral nutrition management team and develop standardized procedures through a quality improvement project. Conduct a 3-month quality improvement initiative, during which regular training sessions will be provided to nurses on gastrointestinal tube placement and maintenance. These training sessions will include various formats such as lectures, group discussions, operational demonstrations, and scenario simulations, along with regular reviews of practical issues.
| Study group | Role | What they receive |
|---|---|---|
| Evidence-based gastric tube placement | Experimental | To implement gastric tube placement management scheme, then observe the continuous changes. Receives: Behavioral: Evidence-based gastric placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compliance rate of gastric tube placement protocols among pediatric nursing staff
The total number of gastric tube placement procedures performed by nursing staff during the study period will be the denominator, while the number of procedures that comply with best evidence practice will be the numerator.
Measured: From baseline to the end of the 3 months implementation
Secondary outcomes (2)
Effects of evidence-based best practice interventions
First-attempt Success Rate of placement: The number of successful placements of the gastric tube at the correct position on the first attempt as the numerator, and the total number of placement attempts as the denominator.
Adverse Event Rate: The number of adverse events occurring during placement as the numerator, and the total number of placement attempts as the denominator.
Measured: From baseline to the end of the 3 months implementation
Pediatric nursing staff's personal knowledge level of gastric tube placement
"Nurses' knowledge of gastric tube placement questionnaire", a self-designed questionnaire was used to compare the correct rate before and after the intervention to test the intervention effect.
Measured: From baseline to the end of the 3 months implementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2025
- Study start26 Jun 2025
- Primary completion30 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hospitalized ChildrenStudies of the same condition, open and under way.
- More trials run by Children's Hospital of Fudan UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2,750 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Collaborators
- Guangzhou Women and Children's Medical Center, Children's Hospital of Chongqing Medical University, Gansu Provincial Maternal and Child Health Care Hospital, Hunan Children's Hospital, The Children's Hospital of Zhejiang University School of Medicine, The First Hospital of Jilin University, Jinan Maternity and Child Health Care Hospital, Henan Provincial People's Hospital, Shengjing Hospital, Shenzhen Children's Hospital, Kunming Children's Hospital, Tongji Hospital, Anhui Provincial Children's Hospital, Children's Hospital of Nanjing Medical University, Children's Hospital of Soochow University, The First People's Hospital of Urumqi （Urumqi Children's Hospital), Peking University First Hospital, Qingdao Women and Children's Hospital, Capital Center for Children's Health,Capital Medical University, Beijing Children's Hospital, West China Second University Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07038538
- Sponsor's protocol ID
- CHFudanU1110
- Status last verified
- Sep 2025
- First submitted
- 11 Nov 2024
- Last updated
- 10 Sep 2025
- Results posted
- No
- Data monitoring committee
- 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 10 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evidence-based Practice in the Management of Gastric Tube Placement in Children: A Multicenter Quality Improvement Project
- ClinicalTrials.gov ID
- NCT07038538
- Acronym / sponsor ID
- CHFudanU1110
- Conditions
- Hospitalized Children, Nursing, Enteral Nutrition Therapy
- Keywords
- Quality Improvement, Before-and-After Comparison, Cognitive and behavior
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 2,750 participants (estimated)
- Lead sponsor
- Children's Hospital of Fudan UniversityUniversity, hospital or other
- Collaborators
- Guangzhou Women and Children's Medical Center, Children's Hospital of Chongqing Medical University, Gansu Provincial Maternal and Child Health Care Hospital, Hunan Children's Hospital, The Children's Hospital of Zhejiang University School of Medicine, The First Hospital of Jilin University, Jinan Maternity and Child Health Care Hospital, Henan Provincial People's Hospital, Shengjing Hospital, Shenzhen Children's Hospital, Kunming Children's Hospital, Tongji Hospital, Anhui Provincial Children's Hospital, Children's Hospital of Nanjing Medical University, Children's Hospital of Soochow University, The First People's Hospital of Urumqi （Urumqi Children's Hospital), Peking University First Hospital, Qingdao Women and Children's Hospital, Capital Center for Children's Health,Capital Medical University, Beijing Children's Hospital, West China Second University Hospital
- Study start
- 26 Jun 2025 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 26 Jun 2025 (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.
This multi-center quality improvement project aims to enhance gastric tube placement practices for children by systematically reviewing the latest evidence. The project team will identify gaps between current practices and best evidence, analyze barriers to implementing evidence-based guidelines, and develop strategies to facilitate their integration into clinical settings. The focus will also be on improving the knowledge and skills of pediatric nurses through targeted education and support. Ultimately, this initiative seeks to ensure the safety and effectiveness of gastric tube placement in the pediatric population, leading to better patient outcomes and higher standards of care.
Detailed description
Enteral nutrition is the preferred method of nutritional support for children with gastrointestinal function, encompassing both oral and tube feeding approaches. Tube feeding involves delivering liquid food, water, and medications directly into the gastrointestinal tract through a feeding tube, making it a primary method of enteral nutrition. Compared to parenteral nutrition, enteral nutrition is more aligned with the body's physiological needs, helping to maintain the intestinal mucosal barrier, protect organ function, and regulate immune responses while being easier to initiate, cost-effective, and associated with a lower risk of infection.
In 2009, the American Society for Parenteral and Enteral Nutrition (ASPEN) published guidelines for enteral nutrition practices, which were updated in 2017. ASPEN also launched the Verification of Enteral Tube Location Project (NOVEL) in 2019, providing clear protocols for the placement of nasogastric tubes in children. Additionally, the European Society for Pediatric Gastroenterology, Hepatology, and Nutrition issued a position statement on nasoenteric feeding for children in 2019.
In China, pediatric clinical nutrition has developed more slowly, but pediatric tube feeding has received growing attention in recent years. The Chinese Society of Parenteral and Enteral Nutrition published clinical application guidelines for pediatric enteral and parenteral nutrition support in 2010, followed by neonatal nutrition support guidelines in 2013. However, there have been no recent updates or standardized procedures for pediatric tube feeding.
This study aims to synthesize the latest evidence on pediatric gastric tube placement and update healthcare professionals' knowledge in pediatric medical institutions, which also seeks to standardize tube placement techniques and apply best practices in clinical settings to enhance the safety and quality of care for children.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Evidence-based gastric tube placement | Experimental | Behavioral: Evidence-based gastric placementTo implement gastric tube placement management scheme, then observe the continuous changes. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Nurses who hold a valid and legal nursing license.
- Nurses who have at least 1 year of clinical nursing experience in pediatric care.
- Hospitalized children Aged 0-18 years.
- Scheduled for nasogastric tube placement.
- Parents or legal guardians have signed the informed consent form, agreeing to the child's participation in the study.
Key exclusion criteria (6 listed)
- Nurses who are on leave or not on duty.
- Nurses working in departments such as the operating room or intravenous compounding center, where nasogastric tube placement is not routinely performed.
- Nurses who are in training or on internships.
- Presence of severe complications or unstable medical conditions.
- Nasogastric tube is intended for gastrointestinal decompression, drainage, or venting.
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 |
|---|---|---|
| Evidence-based gastric placementEstablish an enteral nutrition management team and develop standardized procedures through a quality improvement project. Conduct a 3-month quality improvement initiative, during which regular training sessions will be provided to nurses on gastrointestinal tube placement and maintenance. These training sessions will include various formats such as lectures, group discussions, operational demonstrations, and scenario simulations, along with regular reviews of practical issues. | Behavioural | Evidence-based gastric tube placement |
Primary outcome
Compliance rate of gastric tube placement protocols among pediatric nursing staff
Time frame: From baseline to the end of the 3 months implementation
The total number of gastric tube placement procedures performed by nursing staff during the study period will be the denominator, while the number of procedures that comply with best evidence practice will be the numerator.
2 secondary outcomes
Effects of evidence-based best practice interventions
Time frame: From baseline to the end of the 3 months implementation
Pediatric nursing staff's personal knowledge level of gastric tube placement
Time frame: From baseline to the end of the 3 months implementation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2025.
- 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.
Yuyan Huang contact
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Evidence-based gastric placement in people with Hospitalized Children and Nursing, run by Children's Hospital of Fudan University at 22 sites 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 5 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 10 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ying Gu, Doctor (+86 13816881726, guying0128@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compliance rate of gastric tube placement protocols among pediatric nursing staff (time frame: From baseline to the end of the 3 months implementation). 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 10 Sep 2025.