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

Sponsor

Tokai University (Other)

Overall Status

Completed

CT.gov ID

NCT01545245

Collaborator

Scientific Committee for Elucidation of Infantile Asthma (Other)

343

Enrollment

42.1

Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Atopic Asthma Recurrent Wheezing

Study Design

Study Type:

Observational

Actual Enrollment :

343 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Jul 1, 2010

Actual Primary Completion Date :

Jan 1, 2014

Actual Study Completion Date :

Jan 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Treated Palivizumab treated
Untreated Palivizumab untreated

Outcome Measures

Primary Outcome Measures

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 [For three years]

Secondary Outcome Measures

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 [For three years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

3 Years to 3 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)