NCT05881031 Home Initiation of Noninvasive Positive Pressure Ventilation in Children With Medical Complexity
| NCT ID | NCT05881031 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The Hospital for Sick Children |
| Condition | Sleep-Disordered Breathing |
| Study Type | INTERVENTIONAL |
| Enrollment | 24 participants |
| Start Date | 2023-06-21 |
| Primary Completion | 2026-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 24 participants in total. It began in 2023-06-21 with a primary completion date of 2026-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Children with medical complexity (CMC) often have trouble breathing at night and need to use a breathing machine. This breathing machine is called noninvasive positive pressure ventilation (NiPPV). The use of NiPPV has been shown to improve quality of life and survival in children. Before it is used, NiPPV must first be tested to see what the correct 'machine settings' are for each child. This is usually done in the sleep laboratory at the hospital during a one-night stay. However, sleep studies in the hospital are disruptive and hard for CMC and their families because of the new environment and limited access to the equipment, supplies, comfort items and the routine their child has at home. Patients and families would prefer to start NiPPV at home but there needs to be more research on this to make sure it is possible and safe. This study will evaluate a new model of care to start NiPPV in the home. CMC aged 5-17 years old and starting NiPPV will be assigned at random, like a coin toss, to start NiPPV in the home or to start NiPPV in the sleep laboratory. The investigators will assess the feasibility and safety of the two ways to start NiPPV. This study will be the first step towards developing a study to evaluate if home NiPPV starts are effective. Starting NiPPV at home has the potential to improve the use of NiPPV (ie early adherence predicts long-term use) resulting in both medical benefits as well as improved quality of life for CMC and their families.
Eligibility 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
Contact & Investigator
Reshma Amin, MD
PRINCIPAL INVESTIGATOR
The Hospital for Sick Children
Frequently Asked Questions
Who can join the NCT05881031 clinical trial?
This trial is open to participants of all sexes, aged 60 Months or older, up to 215 Months, studying Sleep-Disordered Breathing. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05881031 currently recruiting?
Yes, NCT05881031 is actively recruiting participants. Contact the research team at Reshma.Amin@sickkids.ca for enrollment information.
Where is the NCT05881031 trial being conducted?
This trial is being conducted at Toronto, Canada.
Who is sponsoring the NCT05881031 clinical trial?
NCT05881031 is sponsored by The Hospital for Sick Children. The principal investigator is Reshma Amin, MD at The Hospital for Sick Children. The trial plans to enroll 24 participants.