Effect of Palivizumab on Later Recurrent Wheezing in Preterm Infants
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.
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|Official Title:||Effect of Palivizumab Treatment on Subsequent Recurrent Wheezing in Preterm Infants: Case-control Study by Scientific Committee of Recurrent Wheezing (SCREW)|
- Cumulative incidence of recurrent wheezing confirmed by physicians [ Time Frame: two years ] [ Designated as safety issue: No ]
- Cumulative incidence of recurrent wheezing confirmed by parents [ Time Frame: two years ] [ Designated as safety issue: No ]
- Incidence of atopic asthma evaluated by SCREW according to the results of the questionnaire and hematological examination [ Time Frame: two years ] [ Designated as safety issue: No ]
- Cumulative incidence of wheezing confirmed by parents [ Time Frame: two years ] [ Designated as safety issue: No ]
- Cumulative incidence of wheezing confirmed by physicians [ Time Frame: two years ] [ Designated as safety issue: No ]
- Number of hospital/clinic visits and hospitalizations due to respiratory-related diseases [ Time Frame: two years ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples Without DNA
|Study Start Date:||March 2008|
|Study Completion Date:||August 2011|
|Primary Completion Date:||December 2010 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01072552
|Tokyo Women's Medical University|
|Shinjuku, Tokyo, Japan, 1628666|
|Study Director:||Sankei Nishima, MD||National Fukuoka Hospital|
|Principal Investigator:||Kenji Okada, MD||National Fukuoka Hospital|