Pulmonary function after mechanical ventilation for respiratory syncytial virus induced respiratory failure in infancy

Withdrawn

• Conditions: bronchiolitis/pneumonia; Respiratory syncytial virus lower respiratory tract infection; 10024970

• Registration Number: NL-OMON36654
• Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Withdrawn
• Sex: Not specified
• Target Recruitment: 120

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))
*For group III: post-operative admittance after elective surgery

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: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Differences in pulmonary function (i.e. airway resistance), one year after<br /><br>hospitalisation for RSV LRTD between mechanically ventilated and non-ventilated<br /><br>infants</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>*Differences in and time course of clinical, virological and immunological<br /><br>characteristics and markers for lung injury between mechanically ventilated and<br /><br>non-ventilated infants<br /><br>*Differences in frequency of recurrent wheezing during the first year following<br /><br>hospitalisation for RSV LRTD between mechanically ventilated infants and<br /><br>non-ventilated infants. Recurrent wheezing is defined by at least one episode<br /><br>of parental reported wheezing (i.e. two or more consecutive days with wheeze)<br /><br>*The frequency of recurrent wheezing in relation to impaired pulmonary function<br /><br>(i.e. airway resistance)</p><br>