Effect of Palivizumab on Later Recurrent Wheezing in Preterm Infants

April 1, 2012 updated by: Satoshi Kusuda

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

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 Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

444

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Tokyo
      • Shinjuku, Tokyo, Japan, 1628666
        • Tokyo Women's Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 months to 1 year (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Infants with the gestational age between 33 and 35 weeks

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Treated
Palivizumab treated
Untreated
Palivizumab untreated

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cumulative incidence of recurrent wheezing confirmed by physicians
Time Frame: two years
two years

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Satoshi Kusuda

Collaborators

Scientific Committee of Recurrent Wheezing

Investigators

  • Study Director: Sankei Nishima, MD, National Fukuoka Hospital
  • Principal Investigator: Kenji Okada, MD, National Fukuoka Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2008

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

August 1, 2011

Study Registration Dates

First Submitted

December 21, 2009

First Submitted That Met QC Criteria

February 19, 2010

First Posted (Estimate)

February 22, 2010

Study Record Updates

Last Update Posted (Estimate)

April 3, 2012

Last Update Submitted That Met QC Criteria

April 1, 2012

Last Verified

April 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SCREW-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Asthma

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Zambia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe