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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01545245

Enrollment

343

Registered

2012-03-06

Start date

2010-07-31

Completion date

2014-01-31

Last updated

2014-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atopic Asthma, Recurrent Wheezing

Keywords

atopic asthma, recurrent wheezing, preterm infants, palivizumab, respiratory syncytial virus, RSV

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

3 Years to 3 Years

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)

Design outcomes

Primary

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	For three years

Secondary

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	For three years

Outcome results