Central And Obstructive Apnoeas In Infants Clinical Trial
Official title:
Improved Discrimination Of Central And Obstructive Apnoeas In Infants
| Verified date | January 2020 |
| Source | Sheffield Children's NHS Foundation Trust |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
Referral of infants to the respiratory sleep disorders breathing team with apnoeas [pauses in
their breathing] and apparent life-threatening episodes are frequent. While the majority of
such episodes do not have a significant underlying problem a potentially life threatening
condition accounts for a significant proportion of cases.
In order to fully assess an infant, a full-scale overnight polysomnography study would be
required. Unfortunately due to the complexity of such studies and because the equipment is
generally fully booked for many weeks ahead it is extremely difficult to arrange timely
assessment. Hence, currently, we are largely reliant on simple screening with pulse oximetry
(measuring oxygen levels in the blood with a simple probe). This is able to identify
potentially significant problems, but it is does not help to determine whether this is
because the baby simply stops breathing for a period due to disturbance of its control of
breathing, or whether it is experiencing obstructive episodes, for which there are a number
of causes. This new equipment to be assessed would potentially provide a simple, robust means
of undertaking definitive studies simply and effectively on the medical wards with assessment
of chest and abdominal wall movement being linked to pulse oximetry.
This is likely to provide a substantial and significant improvement on our current practice.
The benefits will be that, for those with no significant underlying problems, we will be able
to provide much greater reassurance for the parents, which is clearly very valuable, while in
those with a problem we will be able to distinguish those with central or obstructive apnoea
with a degree of certainty that will greatly streamline further assessments and treatment.
| Status | Completed |
| Enrollment | 30 |
| Est. completion date | March 3, 2017 |
| Est. primary completion date | March 3, 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 36 Weeks to 12 Months |
| Eligibility |
Inclusion Criteria: •Infants between 36 weeks post conception and one year old referred to the respiratory and sleep team for central or obstructive apnoea or apparent life threatening events. Exclusion Criteria: •Chest wall deformity on injury that precludes the use of the Volusense paediatric device. |
| Country | Name | City | State |
|---|---|---|---|
| United Kingdom | Sheffield Children's NHS Foundation Trust | Sheffield | Sheffield (South Yorkshire District) |
| Lead Sponsor | Collaborator |
|---|---|
| Sheffield Children's NHS Foundation Trust |
United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Whether comparable to gold standard - cardiorespiratory polysomnogram | To measure the number of central apnoeas, obstructive apnoeas and hyponeas recorded and measured through the night. The apnoea/hyponea index will then be calculated | 74 months | |
| Secondary | To find if Volusense detects central and obstructive apnoea | To measure the number of central apnoeas, obstructive apnoeas and hyponeas recorded and measured through the night. The apnoea/hyponea index will then be calculated | 74 months |