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

Completed

• Conditions: Recurrent Wheezing; Atopic Asthma

• Registration Number: NCT01545245
• Lead Sponsor: Tokai University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-07
• Study First Submitted: 2012-02-29
• Study First Submitted QC: 2012-03-05
• Study First Posted: 2012-03-06
• Primary Completion: 2014-01
• Study Completion: 2014-01
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-05
• Last Update Posted: 2014-12-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 343

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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