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

Tokai University

Status: Completed

Conditions: Atopic Asthma; Recurrent Wheezing

Study type: Observational

Funder types: Other

Identifiers

NCT01545245

SCELIA study

Details and patient eligibility

About

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.

Enrollment: 343 patients

Sex: All

Ages: 3 to 3 years old

Volunteers: No 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)

Trial design

343 participants in 2 patient groups

Treated

Description:

Palivizumab treated

Untreated

Description:

Palivizumab untreated