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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
MedImmune LLC
ClinicalTrials.gov Identifier:
NCT00983606
First received: September 23, 2009
Last updated: November 13, 2012
Last verified: November 2012
  Purpose

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
Healthy

Study Type: Observational
Study Design: 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)

Further study details as provided by MedImmune LLC:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Rate of RSV-associated emergency department (ED) visits during the RSV season [ Time Frame: 2009-2010; 2010- 2011 ] [ Designated as safety issue: No ]
  • Rate of RSV-associated hospitalization during the RSV season [ Time Frame: 2009-2010; 2010-2011 ] [ Designated as safety issue: No ]
  • Rate of risk factors for RSV-associated outpatient LRI, hospitalization, and ED visits [ Time Frame: 2009-2010; 2010-2011 ] [ Designated as safety issue: No ]
  • Rate of risk factors for RSV infection [ Time Frame: 2009-2010; 2010-2011 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Serum (frozen)


Estimated Enrollment: 3000
Study Start Date: September 2009
Study Completion Date: July 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
32 to 35 WGA Infants less than six months of age by RSV season peak.

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.

  Eligibility

Genders Eligible for Study:   Both
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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00983606

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United States, Alabama
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Birmingham, Alabama, United States, 35235
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Birmingham, Alabama, United States, 35209
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LaCrosse, Wisconsin, United States, 54601
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Madison, Wisconsin, United States, 537924108
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Milwaukee, Wisconsin, United States, 53226
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Monroe, Wisconsin, United States, 53566
Sponsors and Collaborators
MedImmune LLC
Investigators
Study Director: Jessie Groothuis, MD MedImmune LLC
  More Information

Additional Information:
No publications provided by MedImmune LLC

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: MedImmune LLC
ClinicalTrials.gov Identifier: NCT00983606     History of Changes
Other Study ID Numbers: MI-MA213
Study First Received: September 23, 2009
Last Updated: November 13, 2012
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on October 29, 2014