Early Life Intervention in Pediatrics Supported by E-health

Status Recruiting

Clinical Trial Summary

Unrestricted parental smoking habits are lifestyle risk behaviors associated with chronic, systemic inflammation, which promotes the pathogenesis of non-communicable diseases (NCDs). Exposure to secondhand tobacco smoke in early life contributes to the development of specific NCDs in children, i.e. asthma. Early preventive measures to improve lifestyle behavior in parents are therefore of utmost importance. The aim of ELIPSE-II is to assess whether an eHealth application intervention for parents is feasible and efficacious in lowering levels of urinary cotinine as a measure of second-hand smoke exposure in their children .

Clinical Trial Description

ELIPSE-II represents a single-blind randomized controlled parallel-group clinical trial. In total, 160 children, <6 years of age with exposure to second-hand smoke at home will be included. Children will be recruited at the children's university hospital and in private practices in Bern, and randomly (1:1) assigned to a control and intervention group. All participants receive treatment-as-usual (TAU), parents of participants in the intervention group additionally receive a smartphone application (lifestyle app) for 20 weeks. The app aims to promote healthy behavior through cognitive-behavioral impact factors (i.e., psychoeducation, goal setting), that are applied by a psychologist via structured feedback. Single-blinded assessments will be conducted at baseline, following the intervention period of 20 weeks, and at 6-month follow-up after the end of the intervention. The primary endpoint is reduction of exposure to second-hand smoke exposure assessed by urinary levels of cotinine. Secondary endpoints in ELIPSE-II include changes in parental smoking habits and effects of the intervention on infants' respiratory health. A further endpoint is acceptance and usability of the app. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06311162
Study type	Interventional
Source	Insel Gruppe AG, University Hospital Bern
Contact	Matthias V. Kopp, Prof. Dr.
Phone	+41 31 66 4 13 51
Email	matthias.kopp@insel.ch
Status	Recruiting
Phase	N/A
Start date	May 7, 2024
Completion date	July 31, 2028

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT04450108` - Vivatmo Pro™ for Fractional Exhaled Nitric Oxide (FeNO) Monitoring in U.S. Asthmatic Patients	N/A
Recruiting	`NCT05734261` - Forced Oscillations Technique During a Metacholine Test in Children	N/A
Recruiting	`NCT06044051` - Dynamics of the Upper and Lower Airway Respiratory Microbiomes Associated With Severe Infant Asthma	N/A
Completed	`NCT04896502` - Effectiveness of Telemedicine Home Assessments for Identification and Reduction of Asthma Triggers	N/A
Completed	`NCT03503812` - Mitigating the Health Effects of Desert Dust Storms Using Exposure-Reduction Approaches	N/A
Recruiting	`NCT06003569` - Reducing Asthma Attacks in Disadvantaged School Children With Asthma	N/A
Not yet recruiting	`NCT05902702` - Isotonic Saline for Children With Bronchiolitis	N/A
Not yet recruiting	`NCT05547477` - Continuous EMG Measurements in Children With Asthma During Sleep
Completed	`NCT04388098` - Oral Health Status of Asthmatic Children
Terminated	`NCT03586544` - Reducing Exercise-induced Bronchoconstriction in Children With Asthma and Obesity	Phase 4
Recruiting	`NCT04821908` - Consequences of COVID 19 Pandemic on Childhood Asthma
Not yet recruiting	`NCT03277170` - Pragmatic RCT of High-dose Oral Montelukast for Moderate and Severe Pediatric Acute Asthma Exacerbations	Phase 2
Enrolling by invitation	`NCT06239844` - Navigating Together for Equitable Asthma Management for Children in Families Who Communicate in Language Other Than English	N/A
Not yet recruiting	`NCT05974917` - Serious gaMes as Emerging E-health Interventions for Young People With neurologicaL or rEspiratory disoRders
Not yet recruiting	`NCT05997784` - Study of Indoor Air Pollutants and Their Impact in Childhood Health and Wellbeing
Recruiting	`NCT05366309` - Performance and Adherence in Children Using Spacers	N/A
Completed	`NCT05684926` - COVID-19 Pandemic Asthma Child Telerehabilitation Yoga	N/A
Recruiting	`NCT04166344` - A mHealth Intervention to Improve Symptom Control in Children and Adolescents With Difficult-to-control Asthma	N/A
Completed	`NCT05576142` - Oral Findings in Pediatric Patients With Allergic Rhinitis and/or Asthma
Completed	`NCT03673618` - Soluble Corn Fiber Supplementation for Asthma	Phase 2

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Early Life Intervention in Pediatrics Supported by E-health - SMOKE — ELIPSE-II

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms