Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

September 23, 2009
November 13, 2012
September 2009
June 2011   (final data collection date for primary outcome measure)
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 ]
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: 2009-2010; 2011 ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00983606 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Rate of RSV-associated emergency department (ED) visits during the RSV season [ Time Frame: 2009-2010; 2011 ] [ Designated as safety issue: Yes ]
  • Rate of RSV-associated hospitalization during the RSV season [ Time Frame: 2009-2010; 2011 ] [ Designated as safety issue: Yes ]
  • Risk factors for RSV-associated outpatient LRI, hospitalization, and ED visits [ Time Frame: 2009-2010; 2011 ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
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)

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

Serum (frozen)

Non-Probability Sample

Premature babies at birth - (32-35 WGA)

Healthy
Not Provided
1
32 to 35 WGA Infants less than six months of age by RSV season peak.
Ambrose CS, Anderson EJ, Simões EA, Wu X, Elhefni H, Park CL, Sifakis F, Groothuis JR. Respiratory syncytial virus disease in preterm infants in the U.S. born at 32-35 weeks gestation not receiving immunoprophylaxis. Pediatr Infect Dis J. 2014 Jun;33(6):576-82. doi: 10.1097/INF.0000000000000219.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
3000
July 2011
June 2011   (final data collection date for primary outcome measure)

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
Both
Not Provided
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00983606
MI-MA213
No
MedImmune LLC
MedImmune LLC
Not Provided
Study Director: Jessie Groothuis, MD MedImmune LLC
MedImmune LLC
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP