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Completed

NCT Number: NCT03385421

Nutritional Practices and Outcomes in Non-Invasive Ventilation

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.

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Key information

Age range

3 day–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Grenoble-Alpes

Grenoble, 38000, France

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Primary outcomes

  1. hospital mortality

    Time frame: 90 days

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Registry information

Acronym: NPO-NIV

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Dec 28, 2017
Registry last updated
Mar 24, 2020

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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