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

Effect of Palivizumab on Later Recurrent Wheezing in Preterm Infants

Sponsors

Lead sponsor: Satoshi Kusuda

Collaborator: Scientific Committee of Recurrent Wheezing

Source Tokyo Women's Medical University
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.

Overall Status Completed
Start Date March 2008
Completion Date August 2011
Primary Completion Date December 2010
Study Type Observational
Primary Outcome
Measure Time Frame
Cumulative incidence of recurrent wheezing confirmed by physicians two years
Secondary Outcome
Measure 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
Enrollment 444
Condition
Eligibility

Sampling method: Non-Probability Sample

Criteria:

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

Gender: All

Minimum age: 3 Months

Maximum age: 1 Year

Healthy volunteers: No

Overall Official
Location
facility Tokyo Women's Medical University
Location Countries

Japan

Verification Date

April 2012

Responsible Party

Responsible party type: Sponsor-Investigator

Investigator affiliation: Tokyo Women's Medical University

Investigator full name: Satoshi Kusuda

Investigator title: Professor of Neonatology

Keywords
Has Expanded Access No
Condition Browse
Arm Group

Arm group label: Treated

Description: Palivizumab treated

Arm group label: Untreated

Description: Palivizumab untreated

Study Design Info

Observational model: Case Control

Time perspective: Prospective

Source: ClinicalTrials.gov