NCT03488303

Brief Summary

The purpose of this study is to evaluate the association of signals recorded and analysed with Ventica® LFTS in infants and preschoolers during acute airway obstruction/asthma exacerbation and recovery thereof for changes in the IP-derived TBFV curves within and between nights.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

March 28, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 4, 2018

Completed
8 days until next milestone

Study Start

First participant enrolled

April 12, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2018

Completed
Last Updated

May 21, 2019

Status Verified

May 1, 2019

Enrollment Period

8 months

First QC Date

March 28, 2018

Last Update Submit

May 20, 2019

Conditions

Obstruction; Airway, With Asthma

Outcome Measures

Primary Outcomes (1)

  • Association between clinical status and tidal breathing flow-volume (TBFV) curves

    Assess the association between clinical status and changes in tidal breathing flow-volume (TBFV) curves measured overnight with Ventica(R) Lung Function Testing System

    2-4 nights while at ward

Secondary Outcomes (2)

  • Association between lung function and tidal breathing flow-volume (TBFV) curves

    2-4 nights while at ward and 2 + 2 nights after discharge from hospital

  • Association between asthma control and tidal breathing flow-volume (TBFV) curves

    2 + 2 nights after discharge from hospital

Study Arms (1)

Main group

Study has only one group

Eligibility Criteria

Age1 Year - 7 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Young children admitted to the ward at the hospital due to acute lower airway obstruction/asthma exacerbation.

You may qualify if:

  • Age 1-7
  • Diagnosis of acute airway obstruction or asthma exacerbation requiring inpatient treatment

You may not qualify if:

  • Need for an ICU treatment
  • Bronchiolitis
  • Pneumonia (not including viral infections)
  • Other cardiorespiratory or neurological chronic diseases or states that may significantly alter the overnight breathing pattern
  • Implanted or external active medical devices

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital Srebrnjak

Zagreb, 10000, Croatia

Location

MeSH Terms

Conditions

Bites and Stings

Condition Hierarchy (Ancestors)

PoisoningChemically-Induced DisordersWounds and Injuries

Study Officials

  • Davor Plavec, MD, PhD

    Children's Hospital Srebrnjak

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 28, 2018

First Posted

April 4, 2018

Study Start

April 12, 2018

Primary Completion

December 20, 2018

Study Completion

December 20, 2018

Last Updated

May 21, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

Locations

CR(1)