Effect of Palivizumab on Later Recurrent Wheezing in Preterm Infants

Sponsor

Satoshi Kusuda (Other)

Overall Status

Completed

CT.gov ID

NCT01072552

Collaborator

Scientific Committee of Recurrent Wheezing (Other)

444

Enrollment

Location

Duration (Months)

10.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Recurrent Wheezing Wheezing Asthma

Study Design

Study Type:

Observational

Actual Enrollment :

444 participants

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)

Study Start Date :

Mar 1, 2008

Actual Primary Completion Date :

Dec 1, 2010

Actual Study Completion Date :

Aug 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Treated Palivizumab treated
Untreated Palivizumab untreated

Outcome Measures

Primary Outcome Measures

Cumulative incidence of recurrent wheezing confirmed by physicians [two years]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

3 Months to 1 Year

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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