Effect of Palivizumab on Later Recurrent Wheezing in Preterm Infants

Completed

• Conditions: Recurrent Wheezing; Wheezing; Asthma

• Registration Number: NCT01072552
• Lead Sponsor: Satoshi Kusuda

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-03
• Study First Submitted: 2009-12-21
• Study First Submitted QC: 2010-02-19
• Study First Posted: 2010-02-22
• Primary Completion: 2010-12
• Study Completion: 2011-08
• Status Verified: 2012-04
• Last Update Submitted: 2012-04-01
• Last Update Posted: 2012-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 444

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cumulative incidence of recurrent wheezing confirmed by physicians	two years

Secondary Outcome Measures

Name	Time	Method
Number of hospital/clinic visits and hospitalizations due to respiratory-related diseases	two years
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

Trial Locations

Locations (1)

Tokyo Women's Medical University; 🇯🇵 Shinjuku, Tokyo, Japan