Effect of Palivizumab on Later Recurrent Wheezing in Preterm Infants

Study Overview
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Brief Summary
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The hypothesis of the present study is that the prophylaxis with palivizumab to prevent the severe RS virus infection during the infancy among preterm infants may reduce the risk of subsequent recurrent wheezing in childhood. The infants born between July 1st and December 31st in 2007 with the gestational age between 33 and 35 weeks were enrolled into the study at the end of RS virus infection season, April 2008. The infants were unintentionally divided into two groups, either palivizumab treated or untreated group at the enrollment, because the timing for palivizumab prophylaxis were already ended. The study infants will be followed up until the age of 3 with recording the incidence of either parent reported or physician diagnosed recurrent wheezing. The difference of the incidence of the recurrent wheezing between the groups will be analyzed with Kaplan-Meier method.

Official Title
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Effect of Palivizumab Treatment on Subsequent Recurrent Wheezing in Preterm Infants: Case-control Study by Scientific Committee of Recurrent Wheezing (SCREW)

Conditions
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Recurrent Wheezing, Wheezing, Asthma

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Infants born July   December 2007 at 33 35 weeks of gestation Exclusion Criteria: Intrauterine growth retardation (less than -2.5SD) Infants with chronic lung disease (CLD) or other respiratory disease Infants received mechanical ventilation. Infants with chronic heart disease (CHD) or congenital anomaly (such as immunodeficiency). Infants received less than 3 doses of palivizumab during the first 6 months of life

Ages Eligible for Study
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Minimum Age: 3 Months
Maximum Age: 1 Year

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Treated<br>Palivizumab treated | |
| Untreated<br>Palivizumab untreated | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative incidence of recurrent wheezing confirmed by physicians |  | two years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative incidence of recurrent wheezing confirmed by parents |  | two years | 
| Incidence of atopic asthma evaluated by SCREW according to the results of the questionnaire and hematological examination |  | two years | 
| Cumulative incidence of wheezing confirmed by parents |  | two years | 
| Cumulative incidence of wheezing confirmed by physicians |  | two years | 
| Number of hospital/clinic visits and hospitalizations due to respiratory-related diseases |  | two years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recurrent wheezing, asthma, preterm infants, palivizumab, atopic diseases