Ventilator induced lung injury by mechanical ventilation in children with respiratory syncytial virus infection.

Completed

• Conditions: bronchiolitis; Respiratory syncytial virus infection; 10024970

• Registration Number: NL-OMON36852
• Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 75

Inclusion Criteria

Index group (n<=25):
* Age < 13 months
* Strong suspicion or proven RSV LRTI (positive PCR or DIFF)
* Respiratory insufficiency requiring mechanical ventilation
Ventilated control group (n<=25):
* Age < 13 months
* Mechanical ventilation for elective surgery (e.g. diagnostic cardiac catheterisation, hernia inguinalis correction)
Non-ventilated control group (n<=25):
* Age < 13 months
* Proven RSV LRTI
* Hospitalisation due to RSV LRTI (e.g. for oxygen suppletion, nasal gastric tube feeding)

Exclusion Criteria

* Previous airway morbidity in all groups
* Severe co-morbidity (p.e. congenital heart disease, prematurity <33 weeks) in the index group
* Current signs of airway infection (runny nose) in the ventilated control group
* Cardiac surgery less than 3 months before elective diagnostic cardiac catheterisation or cyanotic cardic disease in the ventilated control group.

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>An undiluted nasopharyngeal aspirate (NPA) will be taken within 1 hour before<br /><br>intubation followed by an endotracheal aspirate (ETA) at 6, 24 and 48 hours<br /><br>after intubation. In non-intubated patients a NPA will be taken at 0, 6, 24 and<br /><br>48 hours after the first NPA. Cytokine concentrations in NPA /ETA will be<br /><br>determined; IL-1, IL-6, TNF-*, IL-10 and IL-8 will be measured using the<br /><br>Luminex fluorescent-bead-based technology. Of the ventilated patients, 2 ml<br /><br>blood will be collected every 48 hours for immunological studies.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Not applicable</p><br>