Nutritional Practices and Outcomes in Non-Invasive Ventilation

NCT03385421 | Completed

• 1 other identifier: 38RC17.173
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• hospital mortality

  90 days

Eligibility Criteria

• Age: 3 Days - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Population admitted to PICU in whom NIV was initiated

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Grenoble: lead

Study Sites (1)

CHU Grenoble-Alpes

Grenoble, 38000, France

Location

Study Officials

• Katri Typpo

  University of Arizona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator, physician

Study Record Dates

• First Submitted: December 20, 2017
• First Posted: December 28, 2017
• Study Start: March 1, 2017
• Primary Completion: October 10, 2018
• Study Completion: October 10, 2018
• Last Updated: March 24, 2020

Record last verified: 2020-03

Locations

FR (1)