Pediatric patients requiring post-pyloric nutrition under intensive care or with feeding intolerance
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: (1) Patients clinically determined to require post-pyloric feeding (2) Age: Patients under 18 years old at the time of obtaining consent (3) Patients aged 6 months or older at the time of obtaining consent, or if younger than 6 months, patients with a corrected age of >= 37 weeks (4) Weight is >= 2,500g (5) Sex: Both (6) Patients for whom written voluntary consent has been obtained from the patient or their legally acceptable representative after receiving a full explanation and understanding of participation in this study (7) Patients determined by the principal investigator or sub-investigator to be in a general condition capable of enduring the study procedure and 24-hour observation after the procedure
Exclusion criteria
Exclusion criteria: (1) Patients with contraindications for enteral nutrition, such as gastrointestinal perforation, ileus, or peritonitis (2) Patients with structural abnormalities that would make post-pyloric tube placement significantly difficult, such as duodenal atresia (including post-operative status) (3) Patients whose hemodynamic or respiratory status is significantly unstable and for whom the procedure is judged likely to cause deterioration (e.g., shock, severe hypoxemia, frequent arrhythmia) (4) Patients with severe bleeding tendency (5) Patients with a history of severe complications caused by post-pyloric tube placement procedures (6) Other patients judged by the principal investigator or sub-investigator to be unsuitable for participation in this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Success rate of post-pyloric tube placement confirmed by the initial X-ray image after completion of the insertion procedure | — |
Secondary
| Measure | Time frame |
|---|---|
| (1) Time required for the procedure until successful placement (2) Success rate of post-pyloric placement using rescue procedure (3) Frequency and proportion of adverse events related to the procedure | — |
Contacts
The University of Tokyo Hospital