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

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ClinicalTrials.gov Identifier: NCT00983606
Recruitment Status : Completed
First Posted : September 24, 2009
Last Update Posted : November 14, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease
Healthy

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.

Study Design

Study Type : Observational
Estimated Enrollment : 3000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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)
Study Start Date : September 2009
Primary Completion Date : June 2011
Study Completion Date : July 2011
Groups and Cohorts

Group/Cohort
1
32 to 35 WGA Infants less than six months of age by RSV season peak.


Outcome Measures

Primary Outcome Measures :
  1. The primary endpoint is the incidence rate of outpatient RSV LRI during the RSV season, with RSV LRI determined by real time RT-PCR [ Time Frame: Sep. 2009-Feb. 2010; Sep. 2010-Feb. 2011 ]

Secondary Outcome Measures :
  1. Rate of RSV-associated emergency department (ED) visits during the RSV season [ Time Frame: 2009-2010; 2010- 2011 ]
  2. Rate of RSV-associated hospitalization during the RSV season [ Time Frame: 2009-2010; 2010-2011 ]
  3. Rate of risk factors for RSV-associated outpatient LRI, hospitalization, and ED visits [ Time Frame: 2009-2010; 2010-2011 ]
  4. Rate of risk factors for RSV infection [ Time Frame: 2009-2010; 2010-2011 ]

Biospecimen Retention:   Samples Without DNA
Serum (frozen)

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Premature babies at birth - (32-35 WGA)
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00983606


  Show 222 Study Locations
Sponsors and Collaborators
MedImmune LLC
Investigators
Study Director: Jessie Groothuis, MD MedImmune LLC