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NCT Number: NCT07038538

Evidence-based Practice in the Management of Gastric Tube Placement in Children

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.

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Key information

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital of Fudan University, Shanghai, Minhang, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Nurse Inclusion and Exclusion Criteria:

Inclusion:

  • Nurses who hold a valid and legal nursing license.
  • Nurses who have at least 1 year of clinical nursing experience in pediatric care.

Exclusion:

  • 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:

Inclusion:

  • 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.

Exclusion:

  • Presence of severe complications or unstable medical conditions.
  • Nasogastric tube is intended for gastrointestinal decompression, drainage, or venting.

Treatment and study plan

Evidence-based gastric placement

Behavioral

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Effects of evidence-based best practice interventions

    Time frame: From baseline to the end of the 3 months implementation

    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.

  2. Pediatric nursing staff's personal knowledge level of gastric tube placement

    Time frame: From baseline to the end of the 3 months implementation

    "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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ying Gu, Doctor

CONTACT

[email protected]

+86 13816881726

Yuyan Huang

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Children's Hospital of Fudan University

Other

Collaborators

  • Anhui Provincial Children's Hospital
  • Beijing Children's Hospital
  • Capital Center for Children's Health,Capital Medical University
  • Children's Hospital of Chongqing Medical University
  • Children's Hospital of Nanjing Medical University
  • Children's Hospital of Soochow University
  • Gansu Provincial Maternal and Child Health Care Hospital
  • Guangzhou Women and Children's Medical Center
  • Henan Provincial People's Hospital
  • Hunan Children's Hospital
  • Jinan Maternity and Child Health Care Hospital
  • Kunming Children's Hospital
  • Peking University First Hospital
  • Qingdao Women and Children's Hospital
  • Shengjing Hospital
  • Shenzhen Children's Hospital
  • The Children's Hospital of Zhejiang University School of Medicine
  • The First Hospital of Jilin University
  • The First People's Hospital of Urumqi (Urumqi Children's Hospital)
  • Tongji Hospital
  • West China Second University Hospital

Registry information

Official study title

Evidence-based Practice in the Management of Gastric Tube Placement in Children: A Multicenter Quality Improvement Project

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jun 26, 2025
Registry last updated
Sep 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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