The aim of the study is to determine whether children who have been admitted to the ICU for an RSV infection in their first year of life and now are at school age:1. have more respiratory complaints than controls (based on a short questionnaire…
ID
Source
Brief title
Condition
- Ancillary infectious topics
- Respiratory tract infections
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
LCI
Secondary outcome
Number of children in both groups with specific symptoms such as coughing,
wheezing and shortness of breath
Number of children in both groups diagnosed with asthma
Total score, the psychosocial health score and the physical health score
VmaxFRC vs FEV1,
LCI at 1-2 years compared to LCI at 6 years
FEV1, (abs/ %pred/ z-score) FVC, (abs/ %pred/ z-score) FEV1/FVC, (%) FeNO,
Sex
Age in years
Length/height in centimeters / / length sd
Weight in kilograms / weight in height sd
Medication use
Smoking of parents
Family history for asthma
Background summary
98% of children have had an infection with the respiratory tract syncytial
virus (RSV) at the age of 2 years. The RS virus causes infections of the
respiratory tract, including nose, throat, trachea and lungs. Depending on the
severity of the infection, symptoms range from a cold to
a severe respiratory distress. A small part of the children (10%) needs
hospitalization for the treatment of a bronchiolitis or pneumonitis with RSV as
the causative agent. These children have a 30% higher risk of asthma-like
symptoms such as wheezing and have often poor lung function at school age. It
is unclear whether RSV affects the development of asthma or whether children
with asthmatic predisposition
are at risk for a more severe course of RSV bronchiolitis. A follow-up at the
age of 6 years or older will be carried out within the UMCG.
In 2012, we started a follow up program in which children with RSV
bronchiolitis who were admitted to the ICU were invited after 6 months for a
consultation with an infant lung function.
Study objective
The aim of the study is to determine whether children who have been admitted to
the ICU for an RSV infection in their first year of life and now are at school
age:
1. have more respiratory complaints than controls (based on a short
questionnaire based on the ISAAC for 6/7 year olds)
2. are more to have asthma than the general population (ISAAC)
3. experience a comparable quality of life to controls (PedsQLTM questionnaire)
4. have an impaired lung function compared to healthy controls (Spirometry /
MBW / FeNO)
and whether
5. early lung function predicts school-age lung function.
Study design
observational with invasive test (reversibility with salbutamol)
Study burden and risks
Load up to 120 minutes for completing questionnaires and performing lung
function tests. No risk. The study cannot be performed in any other age
category. There is a chance that the lung function tests will show indications
of treatable conditions such as asthma.
Hanzeplein 1
Groningen 9713 GZ
NL
Hanzeplein 1
Groningen 9713 GZ
NL
Listed location countries
Age
Inclusion criteria
For patients
1-born between 2011-2016, at time of measurement 6 years or more
2-hospitalized due to RSV at the PICU between 2012-2016
3-participated at follow up program
4-able to perform spirometry and MBW
For controls: 1 and 4
Exclusion criteria
-Younger than 6 years
-congenital pulmonary disease
-not able to perform spirometry or MBW
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 | NL79581.042.22 |