The primary objective is to study the level and time course of lung inflammation and lung injury of ventilated infants with RSV LRTD. Secondary objective include studying the correlation between the level and time course of lung inflammation and…
ID
Source
Brief title
Condition
- Respiratory tract infections
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter/endpoint is the level of time course of lung
inflammation and lung injury.
Secondary outcome
Secondary study parameters/endpoints include the level and time course of
mechanical ventilation.
Background summary
Respiratory syncytial virus (RSV) is the predominant pathogen of lower
respiratory tract disease (LRTD) in infants. In the
Netherlands ± 5000 infants are annually admitted to hospital due to RSV related
LRTD, approximately 2% - 16% needs to
be mechanically ventilated. Treatment for these infants is supportive;
corticosteroids and bronchodilators are not beneficial
This is mainly due to the fact that the underlying pathophysiological
mechanisms are poorly understood.
Study objective
The primary objective is to study the level and time course of lung
inflammation and lung injury of ventilated infants with RSV LRTD. Secondary
objective include studying the correlation between the level and time course of
lung inflammation and lung injury with the level and time course of mechanical
ventilation of infants with RSV LRTD.
Study design
Prospective, longitudinal cohort-study during four consecutive RSV seasons
(October to March) between 2011 and 2013.
Study burden and risks
Measurements will be performed in all patients at day 1, 3 and 5 of admission
and include: a) blood sampling (2 ml per sampling) using the indwelling
arterial line in ventilated patients, b) endotracheal aspirate, and c)
electrical impedance tomography (EIT) measurements.
There are no specific benefits for enrolled patients because this project is
designed to unravel pathophysiological mechanisms of patients with RSV LRTD.
The risks associated with this project are considered minimal: nurses adhering
to the nursing guideline routinely do obtain endotracheal aspirates in
ventilated children. Blood sampling is done using the indwelling arterial
catheter in ventilated patients. EIT measurements require the use of 16
electrodes: these are comparable to the standard ECG electrodes used.
P.O. Box 30.001
9700 RB Groningen
NL
P.O. Box 30.001
9700 RB Groningen
NL
Listed location countries
Age
Inclusion criteria
- age < 12 months
- admitted with first episode of clinically identified RSV LRTD
- virologically confirmed RSV LRTD
- mechanical ventilation
Exclusion criteria
- age > 12 months
- born after gestational age < 32 weeks
- chronic lung disease of prematurity
- haemodynamically significant congenital heart disorder
- immunodeficiency
- congenital or acquired neuromuscular disorder
- nosocomial RSV infection
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 | NL38779.042.11 |