Home initiation of breathing support for children with complex medical needs
Single Site Feasibility and Safety Study of Home Initiation of Noninvasive Positive Pressure Ventilation in Children With Medical Complexity
This study is testing if starting breathing support at home for children with complex medical needs is safe and effective compared to starting it in the hospital.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 60 Months to 215 Months |
| Sex | All |
| Sponsor | The Hospital for Sick Children Academic / other |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT05881031 on ClinicalTrials.gov |
What this trial studies
This study evaluates the feasibility and safety of starting noninvasive positive pressure ventilation (NiPPV) for children with medical complexity (CMC) in their home environment, rather than in a hospital setting. The research involves randomly assigning participants to either home initiation of NiPPV with remote telemonitoring or the standard in-hospital polysomnography (PSG) method. By assessing the effectiveness of this innovative approach, the study aims to improve adherence to NiPPV and enhance the quality of life for CMC. The study focuses on children aged 5-17 years who are newly prescribed NiPPV and have tolerated an awake trial of the device.
Who should consider this trial
Good fit: Ideal candidates are children aged 5-17 years with medical complexity who have been newly prescribed NiPPV and can tolerate an awake trial of the device.
Not a fit: Patients with severe cardiac disease, high risk of complications from NiPPV, or severe sleep-disordered breathing may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the comfort and adherence of children using breathing support, leading to better health outcomes.
How similar studies have performed: While the standard initiation of NiPPV typically occurs in a hospital, this home-based approach is innovative and has not been widely tested in similar studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age 5-17 years old 2. Newly prescribed NiPPV 3. Tolerated awake NiPPV trial 4. Provides informed consent Exclusion Criteria: 1. Cardiac disease at risk of hemodynamic instability with NiPPV initiation (eg cardiac dysfunction (ejection fraction \<45%), pulmonary hypertension (mean pulmonary artery pressure ≥ 20 mmHg on right heart catheterization or suggestive echocardiogram findings in the opinion of a pediatric cardiologist), or single ventricle) 2. At high risk of complications with NiPPV in the opinion of the child's physician (eg pneumothorax and aspiration risk) 3. Severe sleep disordered breathing with peak CO2 ≥ 60mmHg or apnea-hypopnea index (AHI)≥ 30/hr (AHI measures the number of respiratory events per hour) 4. Participation in concurrent research study that may affect NiPPV adherence (proposed primary outcome of full study) 5. Exclusion of study participants if the caregiver or participant is not English speaking
Where this trial is running
Toronto, Ontario
- The Hospital for Sick Children — Toronto, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Reshma Amin, MD — The Hospital for Sick Children
- Study coordinator: Reshma Amin, MD
- Email: Reshma.Amin@sickkids.ca
- Phone: (416) 813-7654
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.