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

Conditions: ong term respiratory complaints as a possible consequence of RSV bronchiolitis

Registration Number: EUCTR2007-004105-10-NL

Lead Sponsor: Wilhelmina Children's Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

Healthy preterm infants with gestational age between 32 and 35 weeks. Only children of parents who master the Dutch language are included.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Children with a known cardiac anomaly, Down syndrome or other serious congenital disorders are excluded from the study. Also, children with airway morbidity before the start of the RSV season, defined as 1st October of the year of birth will be excluded.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To determine the impact of prevention of RSV LRTI on the development of recurrent wheeze during the first year of life.;Secondary Objective: questionnaire reported wheezing at age 1,3 and 6 years as well as health-related quality of life. Health-related quality of life will be measured during the second winter of life by the TAPQOL questionnaire. Health-economic consequences of RSV will be measured using standard techniques. Direct medical consumption will be measured by determining costs of medication, doctor attendances and hospital admissions. Indirect health-economic consequences will include the number of days of parental absence of work and the degree of parental professional participation during the follow-up period.;Primary end point(s): The primary endpoint of the study is the number of wheezing days during the first year of life.

Secondary Outcome Measures