Skip to main content
OpenTrials
Completed

NCT Number: NCT03824249

Validation of Indirect Calorimetry in Children Undergoing Non-invasive Ventilation

Nutritional status in critically ill pediatric patients is considered a fundamental prognostic factor in terms of mortality, morbidity, complications and outcome. Many studies report how predictive equations most commonly applied are inaccurate, therefore under or over estimating the body energy requirements. For this reason, actual measurement of resting energy expenditure (REE) through indirect calorimetry (IC) is considered to be a better approach.

Currently, IC is not validated during the use of non-invasive ventilation.

Aim of the present study is to validate the measurement of REE with IC in pediatric patients undergoing non-invasive ventilation through a single-limb circuit with intentional leak.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Respiratory Insufficiency in Children Noninvasive Ventilation Nutrition Assessment

Age range

1 month–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milan, 20122, Italy

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • children admitted to the Pediatric Intensive Care Unit who completed the weaning phase from non-invasive ventilation.
  • age ≤ 6 years
  • patients whose parents provided signed informed consent

Exclusion criteria

  • age > 6 years
  • patients whose parents didn't provide signed informed consent

Treatment and study plan

indirect calorimetry

Diagnostic Test

Performance of indirect calorimetry in Canopy mode.

Other names: IC

Primary outcomes

  1. Resting energy expenditure (REE)

    Time frame: 1 day

    Resting energy expenditure expressed in kcal/kg/die

Secondary outcomes

  1. Carbon dioxide production (VCO2)

    Time frame: 1 day

    Quantity of carbon dioxide exhaled by the patients [expressed in ml/kg/min]

  2. Oxygen consumption (VO2)

    Time frame: 1 day

    Quantity of oxygen consumed by the patients [expressed in ml/kg/min]

  3. Respiratory quotient (RQ)

    Time frame: 1 day

    Respiratory quotient [expressed as VCO2/VO2]

Sponsors and collaborators

Lead sponsor

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Other

Registry information

Official study title

Validation of Energy Expenditure Measurement With Indirect Calorimetry in Pediatric Patients Undergoing Non-invasive Ventilation Through a Single-limb Circuit With Intentional Leak: a Single Center, Cross-over, Non Pharmacological Study

Acronym: CALO-NIV

Important dates

Study start
2019
Primary completion
2020
Study completion
2021
First posted
Jan 31, 2019
Registry last updated
Mar 4, 2022

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.