An Observational Study to Assess Respiratory Syncytial Virus (RSV) Respiratory Events Among Premature Infants

An Observational Prospective Study to Assess Respiratory Syncytial Virus (RSV) Respiratory Events Among Premature Infants (32 to 35 Week Gestational Age) - Outcomes and Risk Tracking Study (The Report Study)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00983606

Enrollment

3000

Registered

2009-09-24

Start date

2009-09-30

Completion date

2011-07-31

Last updated

2012-11-14

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

Conditions

Healthy

Brief summary

The primary objective is to assess the burden of respiratory disease in outpatient settings among 32 to 35 weeks' gestational age (wGA) infants in the USA who did not receive RSV prophylaxis during the infants' first RSV season.

Detailed description

The primary objective is to determine the burden of RSV disease in outpatient settings among 32 to 35 wGA infants in the USA who did not receive RSV prophylaxis, as measured by rate of RSV-associated outpatient lower respiratory tract illness (LRI) during the infants' first RSV season.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Yes

Inclusion criteria

* Premature at birth (from 32 weeks and 0 days to 35 weeks and 6 days GA) * Age 6 months or less at the time of screening, and born in May 2009 through January 2010 for Season 1, or May 2010 through February 2011 for Season 2 * Written informed consent and any locally required authorization (eg, HIPAA), obtained from the subject's parent/or guardian prior to performing any protocol-related procedures.

Exclusion criteria

* Receipt of any RSV prophylactic agent: at any time prior to study participation * Participation in studies of investigational RSV prophylaxis or RSV therapeutic agents * Presence of bronchopulmonary dysplasia,hemodynamically significant congenital heart disease, congenital neuromuscular or congenital airway defects * Any condition that, in the opinion of the investigator, would limit life expectancy to less than 6 months

Design outcomes

Primary

Measure	Time frame
The primary endpoint is the incidence rate of outpatient RSV LRI during the RSV season, with RSV LRI determined by real time RT-PCR	Sep. 2009-Feb. 2010; Sep. 2010-Feb. 2011

Secondary

Measure	Time frame
Rate of RSV-associated emergency department (ED) visits during the RSV season	2009-2010; 2010- 2011
Rate of RSV-associated hospitalization during the RSV season	2009-2010; 2010-2011
Rate of risk factors for RSV-associated outpatient LRI, hospitalization, and ED visits	2009-2010; 2010-2011
Rate of risk factors for RSV infection	2009-2010; 2010-2011

Countries

United States

Outcome results