NCT03824249 (CALO-NIV) is a NA clinical trial of Indirect Calorimetry in Respiratory Insufficiency in Children, sponsored by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico.

Who is sponsoring NCT03824249?

NCT03824249 is sponsored by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico.

What drugs are being tested in NCT03824249?

Interventions in NCT03824249: Indirect Calorimetry.

What condition does NCT03824249 study?

NCT03824249 studies Respiratory Insufficiency in Children, Noninvasive Ventilation, Nutrition Assessment.

Is NCT03824249 still recruiting?

NCT03824249 is currently completed. Last updated 4 March 2022.

Last reviewed 2022-03-04 · How we verify

NCT03824249: CALO-NIV

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Validation of Indirect Calorimetry in Children Undergoing Non-invasive Ventilation

Completed NA Last updated 4 March 2022

What this trial tests

NA trial testing Indirect Calorimetry in Respiratory Insufficiency in Children in 20 participants. Completed in 15 December 2021.

Timeline

10 February 2019

Primary endpoint
15 February 2020

15 December 2021

Quick facts

Lead sponsor	Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	diagnostic
Enrollment	20
Start date	10 February 2019
Primary completion	15 February 2020
Estimated completion	15 December 2021
Sites	1 location across Italy

Drugs / interventions tested

Indirect Calorimetry

Conditions studied

Respiratory Insufficiency in Children — all drugs for Respiratory Insufficiency in Children →
Noninvasive Ventilation — all drugs for Noninvasive Ventilation →
Nutrition Assessment — all drugs for Nutrition Assessment →

Sponsor

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Who can join

Adults 1 Month to 6, any sex, with Respiratory Insufficiency in Children or Noninvasive Ventilation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Validation of Indirect Calorimetry in Children Undergoing Single-Limb Non-Invasive Ventilation: A Proof of Concept, Cross-Over Study.
D'Oria V, Spolidoro GCI, Agostoni CV, Montani C, et al · · 2024 · cited 1× · PMID 38257123 · DOI 10.3390/nu16020230

Verify or expand the search:

Other trials of Indirect Calorimetry

Trials testing the same drug.

NCT07535996 — IBM Dietary Surveillance Study · not yet recruiting
NCT06467604 — CRAVE Study: Comparing Craving Responses and Diet Quality of GLP1 Receptor Agonist Users · active not recruiting
NCT05568914 — Intra Dialytic Parenteral Nutrition and Nutritional Gap Nutritional Gap Identified by Indirect Calorimetry · NA · unknown
NCT06221995 — Energy Expenditure in Patients With Ulcerative Colitis Undergoing Surgery · active not recruiting
NCT04535570 — Evolution of the Energy Expenditure During Hematopoietic Stem Cell Transplantation · completed

Other recruiting trials for Respiratory Insufficiency in Children

Currently open trials in the same condition.

NCT07468006 — Comparison of Transcutaneous and Blood CO₂ Measurement in Critically Ill Children · recruiting

Other Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico trials

Trials by the same sponsor.

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NCT07402174 — EIT- Guided Lung Recruitment in pARDS · NA · not yet recruiting
NCT07234097 — The Influence of Music on perceiVed paIn and leVels of Anxiety whiLe unDergoing transperIneal Prostate Biopsy: the VIVAL · NA · not yet recruiting
NCT07317193 — DEFINING THE GENETIC DRIVERS OF ADULT-ONSET CHOLESTATIC LIVER DISEASE · NA · recruiting
NCT07487961 — Assess Abdominal Aortic Diameter in Females · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03824249 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Last refreshed: 4 March 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03824249.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing