NCT03385421

Nutritional Practices and Outcomes in Non-Invasive Ventilation

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 400 (actual)
• Sponsor: University Hospital, Grenoble · Academic / Other
• Sex: All
• Age: 3 Days – 18 Years
• Healthy volunteers: Not accepted

Summary

The Nutritional Practices and Outcomes in Non-Invasive Ventilation (NPO/NIV) study is a collaboration with lead sites from pediatric critical care units within US and Canada, and participating sites from multiple international regions. The goal of NPO/NIV is to understand how non-invasive ventilation (NIV) is used to treat critically ill children and, concurrently, how these children are fed while on NIV. Designed as a period prevalence study, NPO/NIV will collect observational, cross-sectional data over the course of five study weeks. Each study week will require two days of screening for eligible patients. On Mondays, study staff will screen for patients eligible in the previous 48 hours. On Tuesdays, study staff will screen for patients eligible in the previous 24 hours. Patients meeting study inclusion will be eligible to complete V0, V1, and V2. Included patients will be followed for 7 days after the initiation of NIV or until the patient is discharged from the pediatric intensive care unit. This study was granted exempt status by the University of Arizona Human Subjects Protection Program, including a waiver of informed consent. As no personal health information is transmitted during the course of the study, the University of Arizona does not require Data Use Agreements between sites to participate.

Conditions

• Non Invasive Ventilation

Timeline

• Start date: 2017-03-01
• Primary completion: 2018-10-10
• Completion: 2018-10-10
• First posted: 2017-12-28
• Last updated: 2020-03-24

Locations

1 site across 1 country: France