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

Atopic Asthma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01545245
• Other study ID #: SCELIA study
• Status: Completed
• Phase: N/A
• First received: February 29, 2012
• Last updated: December 5, 2014
• Start date: July 2010
• Est. completion date: January 2014

Study information

• Verified date: December 2014
• Source: Tokai University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 343
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Years to 3 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Asthma
• Atopic Asthma
• Recurrent Wheezing
• Virus Diseases

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Tokai University	Scientific Committee for Elucidation of Infantile Asthma

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No