1. To investigate the etiology and incidence of respiratory tract infection in children younger than 6 years of age.2. To investigate the course of respiratory tract infections in children younger than 6 years of age.3. To investigate the clinical…
ID
Source
Brief title
Condition
- Viral infectious disorders
- Respiratory tract infections
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. respiratory virus multiplex PCR
2. clinical symptoms
Secondary outcome
NVT
Background summary
Respiratory tract infections in young children are often caused by respiratory
virusses. The current method to diagnose viral respiratory tract infections is
by use of conventional methods such as immunnefluorescence, immunoblot and cell
culture of the nasopharyngeal washes.
The past few years the Polymerase-Chain-Reaction (PCR) has been set up for more
sensitive and rapid detection of respiratory virus detection in the
nasopharyngeal washes (1,2).
In 2006 the PCR methode has been set up in the AMC and a couple of respiratory
virusses such as enterovirus, influenza A en B, adenovirus, coronavirus (1 t/m
4) humane metapneumovirus, RSV(A&B), parechovirus, parainfluenza virus (1 t/m
4) and rhinovirus acn be evaluated simultaneously by the multiplex-PCR method.
In a previous pilot study we evaluated the clinical symptoms and respiratory
virusses by multiplex-PCR of children under 6 years of age admitted at the Emma
Children's Hospital for a presumed respiratory tract infection. The final data
are currently being analysed.
The purpose of this study is to evaluated in more depth the incidence and
etiology of respiratory tract infections in children under 6 years of age
admitted at the Emma Children's Hospital for a presumed respiratory tract
infection. Furthermore the course of respiratory tract infections will be
evaluated in these children.
The duration of detection of respiratory virusses in nasopharyngeale washes and
the clinical symptoms will be investigated.
A second part of the study is focused on the clinical consequence of a positive
detection of respiratory virusses in nasopharyngeal washes. For this purpose
the recovery of respiratory virusses from nasopharyngeal washes from children
without respiratory tract symptoms will be compared to recovery of respiratory
virusses from nasopharyngeal washes from children with a presumed resipratory
tract infection.
Study objective
1. To investigate the etiology and incidence of respiratory tract infection in
children younger than 6 years of age.
2. To investigate the course of respiratory tract infections in children
younger than 6 years of age.
3. To investigate the clinical consequence of a positive respiratory virus PCR
from nasopharyngeal washes from children without respiratory tract symptoms.
Study design
Children admitted at the Emma Children's hospital with a probable respiratory
tract infection are routinely evaluated by testing the nasopharyngeal washes
for respiratory virusses. These children will be included in the study and a
clinical symptome questionaire is completed by the pediatrician. A follow-up
sample of a nasopharyngeal wash will be perfomed on day 3 and at day 7-14 and
again a clinical symtom questionair is completed.
The nasopharyngeal washes will be evaluated by immunefluorescence, immunoblot
and multiplex PCR.
To gain more insight in the clinical consequence of a positive respiratory PCR
from a nasopharyngeal wash from children under 6 yeras of age without
respiratory tarct symptoms, nasopharyngeal washes will be performed from
children under 6 years of age that visit the outpatient clinic of the Emma
Children's Hospital for outer purposes tha respiratory tract complaints.
Simultaneously a clinical symptom questionaire will be filled out.
This study will be performed during teh wintermonths from december until march.
From an average of 150 patients nasopharyngeal washes are being performed
annually in the Emma Children's Hospital in the AMC. In this study we will
include 100 patients and 100 control studysubjects.
Study burden and risks
The performance of a nasopharyngeal washes causes a short-lasting unpleasant
feeling in teh nose. In this study a total of three nasopharyngesl washes will
be performed and in the control subject only onenasopharyngeal wash. This is a
minimal burden and has only minimal risk. The nasopharyngeal washes are being
performed by trained staff.
meibergdreef 5
1105 AZ Amsterdam
Nederland
meibergdreef 5
1105 AZ Amsterdam
Nederland
Listed location countries
Age
Inclusion criteria
1. Children younger than 6 years of age, admitted at the Emma Children's hospital with a presumed respiratory tract infection
2. Children younger than 6 years of age, admitted at the Emma Children's hospital for another cause than a respiratory infection but with a presumed secundary respiratory infection
3. Children younger than 6 years of age who visit the outpatient clinic of the Emma Children's Hospital for other reasons than presumed respiratory tract infections.
Exclusion criteria
Children older than 6 years of age
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 |
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CCMO | NL15289.018.06 |