Clinical trial NCT05447832: Remote Monitoring in Preschool Wheeze
Official title: Remote Monitoring to Predict and Prevent Asthma Attacks in Preschool Children
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Wheezing
Respiratory Sounds
Keywords: Preschool Wheeze
Asthma Attack
Lead sponsor: Imperial College London
Sponsor class: OTHER
Collaborators: name: Engineering and Physical Sciences Research Council, UK
First posted: 2022-07-07
Enrollment: 100
Sex: ALL
Minimum age (years): 1
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children aged 1-5 years with recurrent wheezing selected from the hospital emergency department and electively investigations.

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.

Detailed description: Asthma is the most common childhood non-infectious lung disease in the United Kingdom, affecting \~8% of children. Asthma symptoms include wheezing (a high-pitched whistling sound created by turbulent airflow through narrowed airways) associated with difficulty in breathing and shortness of breath, often with a dry cough. Asthma is characterised by episodic (wheeze attacks) and variable symptoms which fluctuate day-to-day. An asthma, or wheeze attack, is a sudden worsening of symptoms, associated with airway obstruction that requires treatment to open up the airways.

Preschool children (aged 1-5 years) account for the majority (75%) of hospital admissions for acute attacks of wheezing in the UK. Up to half of all preschool children will suffer at least one episode of wheezing by their 6th birthday, and 7.8% of preschool children came to primary care with acute wheezing in 2017 in the UK. Frequent severe wheeze attacks in preschool age are the strongest risk factor for diminished lung function at physiological peak in early adulthood and are associated with chronic obstructive pulmonary disease (COPD) in the sixth decade of life, as well as early all-cause mortality and cardiovascular and metabolic comorbidities. It is therefore vital to prevent wheeze attacks in preschool children.

Preschool children experience a 5-times higher rate of hospitalisation for acute wheeze attacks compared to school-aged children. This suggests overt symptoms present late, and not soon enough, for early intervention to prevent attacks in preschool children. The number of unscheduled healthcare presentations of acute wheeze attacks has not decreased for the last 2 decades for preschool children, while it has been declining for school-aged children and adults, resulting in a high socioeconomic burden in the UK and worldwide.

Failure to prevent wheeze attacks in preschool children is in part due to the absence of age-specific remote and objective monitoring technology for disease severity. Currently, in this age group, symptoms are diagnosed and monitored by subjective assessments of airway obstruction (narrowing). Evidence that the symptoms improve following treatment with inhaled bronchodilators is used as an indirect indication of the presence of reversible airway obstruction, which is a cardinal feature of asthma. In school-aged children and adults, airway obstruction is monitored objectively with lung function tests such as spirometry. Spirometry can be performed remotely at home to aid telemedicine monitoring in asthma. However, spirometry requires a forced expiratory manoeuvre and cooperation from the patient. It can thus only be reliably performed in children over 5 years old. As a result, diagnosis and monitoring of wheezing/asthma in preschool children depends on parental reports, clinical examination and subjective assessment of symptoms, but no objective measures of airway obstruction.

For this study, time-course lung function data will be obtained using a novel home-based wearable device designed for preschool children that detects airway obstruction whilst the child is asleep (Ventica®). Also, eliciting objective confirmation of wheeze will be obtained by the use of the WheezeScan® device, which detects presence/absence of wheeze when placed on the child's chest. This information will contribute to developing an app that combines symptoms, medication use, and lung function to allow wheeze detection and provide a personalised plan for parents to seek healthcare advice.

STUDY HYPOTHESES

1. A mobile-based system integrating data on remote lung function, symptoms and medication use can be used to predict the development of an acute attack of wheeze in children aged 1-5 years.
2. The dynamic change in lung function reflects underlying airway pathology in severe wheezing

STUDY OBJECTIVES

1. To develop a mobile app system that collects data on lung function, symptoms and medication use, and returns personalised prediction for preschool wheezers, empowering parents to self-manage their child's wheeze/asthma.
2. To quantify airway inflammation and remodelling in endobronchial biopsies and broncho-alveolar lavage from a subgroup of preschool children with severe wheezing and relate pathology to the pattern of airway obstruction detected using the Ventica® system.
3. To develop prediction models that integrate patient-specific abnormal patterns in time-course lung function data, symptoms recorded using with and without WheezeScan®, and rescue medication use, providing early warning of deterioration.

Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Relation of lung function to symptoms and medication use (Group 1)
timeFrame: 2 weeks
measure: Relation of lung function to symptoms and medication use (Group 2)
timeFrame: 4 months
measure: Relation of lung function to airway pathology (Group 2)
timeFrame: 4 months
measure: Develop a prototype app that combine symptoms, medication use and lung function
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Royal Brompton and Harefield NHS Foundation Trust
city: London
country: United Kingdom
facility: Imperial College Healthcare NHS Trust
Study officials:
affiliation: Imperial College London
name: Sejal Saglani, MD
role: PRINCIPAL_INVESTIGATOR
References: