Effects of Preventive Treatment for Respiratory Syncytial (RS) Virus Infection During Infancy on Later Atopic Asthma in Preterm Infants

December 5, 2014 updated by: Hiroyuki Mochizuki, Tokai University

Cohort Study to Evaluate Effects of Prophylactic Treatment for Respiratory Syncytial (RS) Virus Infection in Respiratory Tract During Infancy on Subsequent Atopic Asthma in Preterm Infants

The primary objective of the study is to determine whether the incidence of atopic asthma after three years old may be suppressed in the children who were born as preterm infants and prophylactically treated with palivizumab for respiratory syncytial (RS) virus infections during the infancy.

The secondary objective is to determine whether the incidence of recurrent wheezing after three years old may be suppressed in the children who were born as preterm infants and prophylactically treated with palivizumab for RS virus infections during the infancy.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

343

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 years to 3 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The children who are participating in another on-going study, "Effect of Palivizumab on Later Recurrent Wheezing in Preterm Infants (ClinicalTrials.gov Identifier: NCT01072552)" and whose parents or legal guardian provide informed consent in writing for continuing participation in the study.

Description

Inclusion Criteria:

  • Infants born July ~ December 2007 at 33~35 weeks of gestation
  • Infants administered at least 3 doses of palivizumab during the first 6 months of life (Palivizumab treated)
  • Infants not administered any doses of palivizumab during the first 6 months of life (Palivizumab untreated)

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)

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

Cohorts and Interventions

Group / Cohort
Treated
Palivizumab treated
Untreated
Palivizumab untreated

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The incidence of atopic asthma after three years old in the children who were born as preterm infants and prophylactically treated with palivizumab for RS virus infections during the infancy
Time Frame: For three years
For three years

Secondary Outcome Measures

Outcome Measure
Time Frame
The incidence of recurrent wheezing after three years old in the children who were born as preterm infants and prophylactically treated with palivizumab for RS virus infections during the infancy
Time Frame: For three years
For three years

Collaborators and Investigators

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

Sponsor

Tokai University

Collaborators

Scientific Committee for Elucidation of Infantile Asthma

Investigators

  • Principal Investigator: Hiroyuki Mochizuki, M.D., Ph.D.,, Professor, Department of Pediatrics, Tokai University School of Medicine

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

July 1, 2010

Primary Completion (Actual)

January 1, 2014

Study Completion (Actual)

January 1, 2014

Study Registration Dates

First Submitted

February 29, 2012

First Submitted That Met QC Criteria

March 5, 2012

First Posted (Estimate)

March 6, 2012

Study Record Updates

Last Update Posted (Estimate)

December 8, 2014

Last Update Submitted That Met QC Criteria

December 5, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SCELIA study

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.

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