Nutritional Practices and Outcomes in Non-Invasive Ventilation

Non Invasive Ventilation Clinical Trial

— NPO-NIV  

Official title:

Nutritional Practices and Outcomes in Non-Invasive Ventilation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03385421
• Other study ID #: 38RC17.173
• Status: Completed
• Start date: March 1, 2017
• Est. completion date: October 10, 2018

Study information

• Verified date: March 2020
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: October 10, 2018
• Est. primary completion date: October 10, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

Inclusion Criteria:

• Patient admitted to the Pediatric ICU

• in whom noninvasive ventilation (NIV) was initiated within previous 48 hours (NIV use includes any High Flow Nasal Canula > 2 lpm flow , continuous positive airway pressure or bilevel pressure or neurally adjusted ventilatory assist)

Exclusion Criteria:

Patients with:

• chronic home NIV use for >12 hours per day

• limitations of care decisions made

• Cardiac surgery during this admission

• Acute gastro intestinal bleeds

• Abdominal surgery in previous 48 hours

• Gut graft versus host disease

• Chronic parenteral nutrition

• Short Gut Syndrome

Related Conditions & MeSH terms

• Non Invasive Ventilation

Locations

Country	Name	City	State
France	CHU Grenoble-Alpes	Grenoble

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	hospital mortality		90 days