Effect of palivizumab on respiratory syncytial virus-associated burden of disease - a randomized controlled trial

Recruiting

• Conditions: bronchiolitis; lower respiratory tract infection; 10047438; 10013369

• Registration Number: NL-OMON47056
• Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 18 June 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 452

Inclusion Criteria

gestational age 32-35 weeks

Exclusion Criteria

known congenital heart disease
serious congenital disease
Down Syndrome

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Number of wheezing days during the first year of life as noted in a log by<br /><br>parents<br /><br>Follow-up at the age of 6 year:<br /><br>Determination or exclusion of asthma and allergy, transcriptome </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Health-related quality of life determined with a validated questionnaire<br /><br>(TAPQOL)<br /><br>Long function testing and allergy testing, transcriptome analysis at age 6<br /><br>years.<br /><br>Whole genome methylation at age 7 years<br /><br>Genome wide association study (GWAS) between the age of 6-8 years.<br /><br>Additional research about specific antibodies against RSV</p><br>