NCT02373683

Brief Summary

The aim of this prospective pilot study is to determine the effect of heliox delivered via a proprietary calibrated heated and humidified high flow nasal cannula (HFNC) system (Vapotherm Precision Flow Heliox) in children ages 0-24 months with severe bronchiolitis.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2014

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 23, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 27, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
6.3 years until next milestone

Results Posted

Study results publicly available

March 2, 2022

Completed
Last Updated

March 2, 2022

Status Verified

February 1, 2022

Enrollment Period

11 months

First QC Date

February 23, 2015

Results QC Date

January 4, 2022

Last Update Submit

February 7, 2022

Conditions

BronchiolitisHelioxPediatrics

Outcome Measures

Primary Outcomes (1)

  • Respiratory Assessment Score

    Change in the respiratory assessment score from baseline (within 15 minutes of extubation) to 48 hours after extubation. The score ranges from 0 to 12, with higher scores indicating worsening respiratory distress.

    48 hours

Secondary Outcomes (4)

  • Need for Reintubation

    During hospitalization, typically 4 days to 2 weeks

  • PICU Length of Stay

    During hospitalization, typically 4 days to 2 weeks

  • Hospital Length of Stay

    During hospitalization, typically 4 days to 2 weeks

  • Length of Treatment With Supplemental Oxygen

    During hospitalization, typically 4 days to 2 weeks

Study Arms (2)

Vapotherm-Heliox

EXPERIMENTAL

Following separation from mechanical ventilation, patient is placed on heliox (70% oxygen-30% helium) delivered with Vapotherm, a proprietary heated, humidified, high-flow nasal cannula delivery system.

Device: Vapotherm-Heliox

Standard Care

NO INTERVENTION

Care dictated by clinical team.

Interventions

Vapotherm-HelioxDEVICE

Following separation from mechanical ventilation, patient is placed on heliox (70% oxygen-30% helium) delivered with Vapotherm, a proprietary heated, humidified, high-flow nasal cannula delivery system.

Vapotherm-Heliox

Eligibility Criteria

AgeUp to 2 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children 0-24 months
  • Admission to the Pediatric Intensive Care Unit
  • Diagnosis of bronchiolitis, with respiratory syncytial virus infection confirmed by laboratory testing
  • Mechanical ventilation

You may not qualify if:

  • Significant cardiac disease
  • Anatomically abnormal airway
  • Neurologic disease
  • Immunodeficiency
  • History of chronic lung disease
  • Craniofacial anomaly
  • Chromosomal anomalies
  • Known or suspected dysphagia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rainbow Babies Children's Hospital, University Hospitals Case Medical Center

Cleveland, Ohio, 44106, United States

Location

Related Publications (10)

  • Nair H, Nokes DJ, Gessner BD, Dherani M, Madhi SA, Singleton RJ, O'Brien KL, Roca A, Wright PF, Bruce N, Chandran A, Theodoratou E, Sutanto A, Sedyaningsih ER, Ngama M, Munywoki PK, Kartasasmita C, Simoes EA, Rudan I, Weber MW, Campbell H. Global burden of acute lower respiratory infections due to respiratory syncytial virus in young children: a systematic review and meta-analysis. Lancet. 2010 May 1;375(9725):1545-55. doi: 10.1016/S0140-6736(10)60206-1.

    PMID: 20399493BACKGROUND

  • Chowdhury MM, McKenzie SA, Pearson CC, Carr S, Pao C, Shah AR, Reus E, Eliahoo J, Gordon F, Bland H, Habibi P. Heliox therapy in bronchiolitis: phase III multicenter double-blind randomized controlled trial. Pediatrics. 2013 Apr;131(4):661-9. doi: 10.1542/peds.2012-1317. Epub 2013 Mar 18.

    PMID: 23509160BACKGROUND

  • Martinon-Torres F, Rodriguez-Nunez A, Martinon-Sanchez JM. Heliox therapy in infants with acute bronchiolitis. Pediatrics. 2002 Jan;109(1):68-73. doi: 10.1542/peds.109.1.68.

    PMID: 11773543BACKGROUND

  • Kim IK, Phrampus E, Sikes K, Pendleton J, Saville A, Corcoran T, Gracely E, Venkataraman S. Helium-oxygen therapy for infants with bronchiolitis: a randomized controlled trial. Arch Pediatr Adolesc Med. 2011 Dec;165(12):1115-22. doi: 10.1001/archpediatrics.2011.605.

    PMID: 22147778BACKGROUND

  • Gupta VK, Cheifetz IM. Heliox administration in the pediatric intensive care unit: an evidence-based review. Pediatr Crit Care Med. 2005 Mar;6(2):204-11. doi: 10.1097/01.PCC.0000154946.62733.94.

    PMID: 15730610BACKGROUND

  • Liet JM, Ducruet T, Gupta V, Cambonie G. Heliox inhalation therapy for bronchiolitis in infants. Cochrane Database Syst Rev. 2010 Apr 14;(4):CD006915. doi: 10.1002/14651858.CD006915.pub2.

    PMID: 20393951BACKGROUND

  • Abboud PA, Roth PJ, Skiles CL, Stolfi A, Rowin ME. Predictors of failure in infants with viral bronchiolitis treated with high-flow, high-humidity nasal cannula therapy*. Pediatr Crit Care Med. 2012 Nov;13(6):e343-9. doi: 10.1097/PCC.0b013e31825b546f.

    PMID: 22805160BACKGROUND

  • Bressan S, Balzani M, Krauss B, Pettenazzo A, Zanconato S, Baraldi E. High-flow nasal cannula oxygen for bronchiolitis in a pediatric ward: a pilot study. Eur J Pediatr. 2013 Dec;172(12):1649-56. doi: 10.1007/s00431-013-2094-4. Epub 2013 Jul 31.

    PMID: 23900520BACKGROUND

  • Milesi C, Baleine J, Matecki S, Durand S, Combes C, Novais AR, Cambonie G. Is treatment with a high flow nasal cannula effective in acute viral bronchiolitis? A physiologic study. Intensive Care Med. 2013 Jun;39(6):1088-94. doi: 10.1007/s00134-013-2879-y. Epub 2013 Mar 14.

    PMID: 23494016BACKGROUND

  • Schibler A, Pham TM, Dunster KR, Foster K, Barlow A, Gibbons K, Hough JL. Reduced intubation rates for infants after introduction of high-flow nasal prong oxygen delivery. Intensive Care Med. 2011 May;37(5):847-52. doi: 10.1007/s00134-011-2177-5. Epub 2011 Mar 3.

    PMID: 21369809BACKGROUND

MeSH Terms

Conditions

Bronchiolitis

Condition Hierarchy (Ancestors)

BronchitisRespiratory Tract InfectionsInfectionsBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung Diseases

Results Point of Contact

Title
Katherine Slain
Organization
Case Western Reserve University
katherine.slain@uhhospitals.org
12168443310

Study Officials

  • Alexandre Rotta, MD

    Rainbow Babies and Children's Hospital, University Hospitals Case Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
DO

Study Record Dates

First Submitted

February 23, 2015

First Posted

February 27, 2015

Study Start

December 1, 2014

Primary Completion

November 1, 2015

Study Completion

November 1, 2015

Last Updated

March 2, 2022

Results First Posted

March 2, 2022

Record last verified: 2022-02

Locations

US(1)