The aim of this study is to establish reference values of exhaled nitric oxide (eNO) using the tidal breathing offline method in healthy children aged 12 - 48 months (1 - 4 years old).
ID
Source
Brief title
Condition
- Lower respiratory tract disorders (excl obstruction and infection)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
exhaled NO (in parts per billion)
The mean eNO concentration, the standard deviation and the 95% reference
interval (RI) for the eNO will be calculated. The 95% reference interval will
be considered as reference values.
Secondary outcome
Not applicable
Background summary
Nitric oxide in exhaled air (FeNO, fractional exhaled nitric oxide) is a marker
of airway inflammation. Airway inflammation is a characteristic feature of
asthma, so measurement of FeNO is a useful test for diagnosing and monitoring
asthma. Because measurement of FeNO is a non-invasive procedure, it is
extremely useful for children.
For adults and children older than 6 years of age, recommendations for
standardized procedures for FeNO measurement have been outlined. However, for
these standardized procedures, considerable collaboration on the part of the
patient is necessary, which is almost impossible in children younger than 5
years of age. For children younger than 5 years of age, several methods for
eNO-measurement have been developed, which only require passive collaboration
of the child. One of these methods is the tidal breathing offline
eNO-measurement: no sedation is needed and the method is easily applicable in
toddlers. Although this method was described several times, no reference values
are available for children aged 1 - 4 years old. Before tidal breating offline
eNO-measurement can be used in daily practice, reliable reference values have
to be established for this group of children.
Study objective
The aim of this study is to establish reference values of exhaled nitric oxide
(eNO) using the tidal breathing offline method in healthy children aged 12 - 48
months (1 - 4 years old).
Study design
We will measure eNO once in 50 healthy children aged 12 - 48 months (1 - 4
years old), using the tidal breathing offline method. When the child is in its
mother's or the investigator's lap, the exhaled air of the child is collected
in 2 balloons using a face mask. The NO-concentration in the exhaled air will
be analysed the same day, using the NO-analysator (Niox flex). NO-measurement
is an ozon/NO2-based chemiluminescence reaction. The NO in the balloon remains
stable during 9 hours.
Study burden and risks
There is no significant burden for the participants: when the child is in its
mother's or the investigator's lap, the exhaled air of the child is collected
in 2 balloons using a face mask. When the child offers resistance (for example
crying or pushing the face mask away), the measurement will be stopped.
The study involves no risks for the participants.
Weg door Jonkerbos 100
6532 SZ Nijmegen
Nederland
Weg door Jonkerbos 100
6532 SZ Nijmegen
Nederland
Listed location countries
Age
Inclusion criteria
Healthy children aged 12 - 48 months (1 - 4 years old)
Exclusion criteria
- Medical history of: asthma, viral wheeze, eczema, allergic rhinitis or other allergies/pulmonary diseases
- An active upper or lower respiratory tract infection during the eNO-measurement
- Medication: β2-sympathicomimetics, inhalation corticosteroids, leukotriene receptor antagonists or antihistamines
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL30243.091.09 |