The primary objective is a) to study the occurrence of recurrent wheezing following hospitalisation for severe RSV LRTD, and to study the differences in occurrence between ventilated and non-ventilated infants, and ) to study differences in lung…
ID
Source
Brief title
Condition
- Respiratory tract infections
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- To study the occurrence of recurrent wheezing following hospitalisation for
severe RSV LRTD, and to study the differences in occurrence between ventilated
and non-ventilated infants
- To study differences in lung function testing one year after hospitalisation
for RSV LRTD between ventilated and non-ventilated infants
Secondary outcome
To study the differences in clinical, virological and immunological
characteristics in relation to recurrent wheezing following hospitalisation for
severe RSV LRTD between ventilated and non-ventilated infants.
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 (3). RSV
LRTD leads to serious respiratory sequelae with ± 50% of hospitalised patients
suffering from recurrent wheezing resembling childhood asthma persisting until
early school age. significant proportion of patients with recurrent wheezing
receive asthma medications and experience decreased health-related quality of
life. Furthermore, hospitalized infants have impaired lung function during
follow-up compared to healthy controls. We hypothesize that recurrent wheezing
after severe RSV LRTD occurs significantly more often in ventilated than in
non-ventilated infants. This is explained by a higher viral load, a more
dampened T * cell response and more lung injury (defined by circulating
biomarkers) in ventilated infants. One year after severe RSV LRTD, airway
resistance is significantly higher in ventilated infants than in non-ventilated
infants.
Study objective
The primary objective is a) to study the occurrence of recurrent wheezing
following hospitalisation for severe RSV LRTD, and to study the differences in
occurrence between ventilated and non-ventilated infants, and ) to study
differences in lung function testing one year after hospitalisation for RSV
LRTD between ventilated and non-ventilated infants. Secondary objectives are to
study the differences in clinical, virological and immunological
characteristics in relation to recurrent wheezing following hospitalisation for
severe RSV LRTD between ventilated and non-ventilated infants.
Study design
This is a prospective, longitudinal cohort-study of patients admitted with RSV
lower respiratory tract infection to the Beatrix Children*s Hospital/University
Medical Center Groningen comprising four consecutive RSV seasons (October to
March) between 2010 and 2014.
Study burden and risks
Measurements will be performed in all infants on day 1, 3 and 5 of admission
including blood sampling (2 ml per sampling) through a venous puncture in
non-ventilated infants, and obtaining nasopharyngeal aspirates. In ventilated
infants measurements will also be performed on day 1, 3 and 5 of admission
including blood sampling (2 ml per sampling) using the indwelling arterial
line, obtaining nasopharyngeal aspirates and obtaining broncho-alveolar lavage
fluids. Regional lung filling characteristics will be measured using electrical
impedance tomography (EIT). During the first year of follow-up parents or legal
care-takers of all included infants are asked to daily fill out a patient
diary, recording respiratory symptoms including cough, rhinitis, wheezing, and
consultation of a physician and use of bronchodilators. One year after
discharge, lung function testing including FRC and airway resistance will be
performed with the whole-body plethysmography in all included infants.
The risks associated with this project are considered minimal: ventilated
infants who undergo a broncho-alveolar lavage may experience a brief period of
a decrease in transcuteaneously measured oxygen saturation. Obtaining a
nasopharyngeal aspirate in infants does not cause any extra risk, but may be
experienced is uncomfortable for a brief period in non-ventilated infants.
Blood sampling is done using the indwelling arterial catheter in ventilated
infants; however in non-ventilated infants a venous puncture has to be
performed. Lung function testing one year after discharge requires the infant
to be mildly sedated using oral chloralhydrate; because of this a physician
trainined in advanced paediatric life support will be present during this
procdure.
P.O. Box 30.001
9700 RB Groningen
Nederland
P.O. Box 30.001
9700 RB Groningen
Nederland
Listed location countries
Age
Inclusion criteria
- Age < 12 months
- Admitted with a first episode of RSV LRTD as defined with one or more of the following signs and symptoms: body temperature * 37.5° C, cough, rhinitis, wheezing on pulmonary auscultation, and crackles on pulmonary auscultation
-Virogically confirmed RSV LRTD (i.e. a positive direct immunofluorescent assay (DIFA) or a positive RSV-enzyme immunoassay (EIA)
Exclusion criteria
- Age * 12 months
- Infants born after a gestation * 32 weeks
- Infants with chronic lung disease of prematurity (defined by oxygen dependency between 28 and 56 days after birth)
- Infants with a haemodynamically significant congenital heart disorder
- Infants with an immunodeficiency
- Infants with a congenital or acquired neuromuscular disorder
- Infants managed only in the outpatient department
- Infants with a nosocomial (i.e. hospital acquired) RSV LRTD
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 | NL31181.042.09 |