Remote Monitoring in Preschool Wheeze

NCT05447832 | Unknown

• 1 other identifier: 307300
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 2

Brief Summary

The aim of this project is to fill the significant unmet healthcare need to prevent wheeze attacks in preschool children. This will be achieved by developing a proof-of-concept, bespoke home remote objective monitoring system for preschool children that can identify early signs before a wheeze attack to allow early intervention and prevention. This study aims to develop methods for recognising child-specific abnormal patterns in time-course lung function data, and wheeze onset providing early warning of deterioration. The prototype system is targeted for use by caregivers of preschool children with wheeze, and will integrate the individual child's information about symptoms, medication use and lung function to alert parents to seek healthcare advice to prevent hospitalisation.

Conditions

Wheezing; Respiratory Sounds

Keywords

Preschool Wheeze; Asthma Attack

Outcome Measures

Primary Outcomes (4)

• Relation of lung function to symptoms and medication use (Group 1)

  The lung function measured with the Ventica® system measures tidal breathing variability (non-invasive) in order to assist with the diagnosis and monitoring of asthma or asthmatic symptoms in children aged five years and under. It includes 4 electrodes that are placed under the child's arms - with wires that connect to a small recorder, which is included in a vest that is worn overnight. The presence of wheeze would be detected with the WheezeScan® device, this device needs to be placed on the child's chest for 30-60 seconds and it will confirm if wheezing is present. This will be used by families either when they think their child has symptoms or routinely just prior to the lung function monitoring equipment being used. Both devices include European Conformity (CE) certification and are available for purchase commercially. Symptoms and medication use will be collected using an online secure questionnaire that will be accessible from a computer or a mobile phone.

  2 weeks

• Relation of lung function to symptoms and medication use (Group 2)

  The lung function measured with the Ventica® system measures tidal breathing variability (non-invasive) in order to assist with the diagnosis and monitoring of asthma or asthmatic symptoms in children aged five years and under. It includes 4 electrodes that are placed under the child's arms - with wires that connect to a small recorder, which is included in a vest that is worn overnight. The presence of wheeze would be detected with the WheezeScan® device, this device needs to be placed on the child's chest for 30-60 seconds and it will confirm if wheezing is present. This will be used by families either when they think their child has symptoms or routinely just prior to the lung function monitoring equipment being used. Both devices include European Conformity (CE) certification and are available for purchase commercially. Symptoms and medication use will be collected using an online secure questionnaire that will be accessible from a computer or a mobile phone.

  4 months

• Relation of lung function to airway pathology (Group 2)

  Information of patients having a planned bronchoscopy will be collected, to relate airway inflammation and remodelling in bronchial biopsies and broncho-alveolar lavage to the pattern of airway obstruction detected using the Ventica® lung function monitoring system. The endobronchial biopsies will quantify the changes that may cause a child to have wheezing, this includes the amount of mucus, smooth muscle and collagen in the biopsy. The results from these analyses will be related to the lung function measurements, to assess whether specific types of changes in the airway samples relate to specific types of changes in lung function.

  4 months

• Develop a prototype app that combine symptoms, medication use and lung function

  The mobile app system will collect data on lung function, symptoms and medication use, and will return personalised predictions for preschool wheezers. The prediction model of attacks and loss of symptom control will be trained using the longitudinal data obtained from the children in the study. Change in lung function, and time to normalisation following treatment for wheezing, will be assessed to understand the time taken for full recovery, and whether persistently abnormal lung function, without overt symptoms, may be an early and sensitive sign for a future attack. The relative contributions of each parameter (symptoms, medication use, wheeze detection, lung function, lower airway inflammation) in determining the accuracy of the model will be assessed to determine the added value of lung function monitoring in predicting individualised patterns of loss of control.

  4 months

Study Arms (2)

1/Children aged between 1-5 years from the emergency department

Children who have attended the emergency department at St Mary's Hospital, with an acute attack of wheezing. These families will be asked to use the lung function monitoring and the wheeze detection device every night for 2 weeks, while recording symptoms and medication use in the last 24 hours.

Device: Lung function monitoring equipment at home - 2 weeks

2/Children aged between 1-5 years admitted electively for wheezing investigation

Children who have been admitted electively for investigations of their wheezing at the Brompton Hospital. These children/families will be asked to do the lung function monitoring and the wheeze detection device once per week for 4 months, while recording symptoms and medication use in the last 24 hours.

Device: Lung function monitoring equipment at home - 4 months; Diagnostic Test: Inflammation and remodelling from clinical indicted bronchoscopy

Interventions

Lung function monitoring equipment at home - 2 weeks DEVICE

The parent/carer setup the lung function monitoring equipment (Ventica®), and placed the WheezeScan® device on the child's chest at home before the child goes to sleep. This is performed once daily for 2 weeks.

1/Children aged between 1-5 years from the emergency department

Lung function monitoring equipment at home - 4 months DEVICE

The parent/carer setup the lung function monitoring equipment (Ventica®), and placed the WheezeScan® device on the child's chest at home before the child goes to sleep. This is performed once weekly for 4 months.

2/Children aged between 1-5 years admitted electively for wheezing investigation

Inflammation and remodelling from clinical indicted bronchoscopy DIAGNOSTIC_TEST

For patients who are undergoing clinically indicated bronchoscopy, consent will be obtained to use any surplus clinical samples for this study. The samples to be collected are broncho-alveolar lavage and endobronchial biopsies. Both of these are taken from the airways during clinical bronchoscopy.

2/Children aged between 1-5 years admitted electively for wheezing investigation

Eligibility Criteria

• Age: 1 Year - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children aged 1-5 years with recurrent wheezing selected from the hospital emergency department and electively investigations.

You may qualify if:

• Children aged 1-5 years
• Doctor diagnosed and confirmed wheeze
• At least one previous attack of wheeze in the previous year
• Parents/carers with access to a smart phone or computer (to allow data to be entered into the online questionnaire)

You may not qualify if:

• Prematurity \< 34 weeks gestation
• Need for ventilation in the first seven days after birth
• Known cardiac disease
• Known diagnosis of another respiratory condition (e.g. cystic fibrosis, bronchiectasis)

Sponsors & Collaborators

• Imperial College London: lead
• Engineering and Physical Sciences Research Council, UK: collaborator

Study Sites (2)

Royal Brompton and Harefield NHS Foundation Trust

London, SW3 6NP, United Kingdom

Location

Imperial College Healthcare NHS Trust

London, W2 1BL, United Kingdom

Location

MeSH Terms

Conditions

Respiratory Sounds

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Sejal Saglani, MD

  Imperial College London

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sejal Saglani, MD

CONTACT

+442075943167; s.saglani@imperial.ac.uk

Karina Mayoral, MPH

CONTACT

k.mayoral-ortiz21@imperial.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 23, 2022
• First Posted: July 7, 2022
• Study Start: August 1, 2022
• Primary Completion: November 29, 2023
• Study Completion: March 29, 2024
• Last Updated: July 7, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)