The effect of severe respiratory syncytial virus (RSV) lower respiratory tract infections in mechanically ventilated infants younger than 12 months of age on recurrent wheezing and lung functio

Withdrawn

Conditions: bronchiolitis/pneumonia
RSV lower respiratory tract infection
10024970

Registration Number: NL-OMON34923

Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Withdrawn

Sex: Not specified

Target Recruitment: 70

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

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>- To study the occurrence of recurrent wheezing following hospitalisation for<br /><br>severe RSV LRTD, and to study the differences in occurrence between ventilated<br /><br>and non-ventilated infants<br /><br>- To study differences in lung function testing one year after hospitalisation<br /><br>for RSV LRTD between ventilated and non-ventilated infants</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>To study the differences in clinical, virological and immunological<br /><br>characteristics in relation to recurrent wheezing following hospitalisation for<br /><br>severe RSV LRTD between ventilated and non-ventilated infants.</p><br>