Ignite Creation Date:
2024-05-05 @ 5:04 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00384462
Status:
COMPLETED
Last Update Posted:
2009-02-04
First Post:
2006-10-04
Brief Title:
Study to Evaluate the Incidence of Hospitalizations and Respiratory Tract Infections in Premature Infants
Sponsor:
MedImmune LLC
Organization:
MedImmune LLC
Study Overview
Official Title:
A Prospective Non-Interventional Study to Evaluate the Incidence of Hospitalizations and Medically-Attended Lower Respiratory Tract Infection MALRI in Premature Infants 32 to 35 Weeks Gestational Age Who Are Not Recommended to Receive Prophylaxis for RSV
Status:
COMPLETED
Status Verified Date:
2009-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to describe respiratory syncytial virus RSV hospitalization rates and to begin to address the utilization of outpatient resources for RSV medically-attended lower respiratory tract infections MALRI in 32-35 week gestational age GA premature infants who are less than 6 months of age and do not receive treatment
Detailed Description:
The goals of this study are
To estimate the incidence of hospitalization attributable to RSV within 150 days from enrollment in premature infants who are
32-35 weeks GA
less than 6 months of age at the start of the RSV season
not receiving palivizumab prophylaxis and not recommended to receive palivizumab according to the AAP guidelines
To estimate the incidence rate of hospitalization attributable to RSV in the other relevant study populations and time periods eg Cohort 2 Cohorts 1 and 2 combined and subgroups based on chronological age at the start of the RSV season GA etc within 150 days from enrollment and other time periods based on RSV activity etc
To estimate the incidence of RSV-associated MALRI in the study populations
To characterize the incidence and type of clinical interventions for MALRI in the study populations
To estimate the incidence of hospitalization attributable to RSV within 150 days from enrollment in premature infants who are
32-35 weeks GA
less than 6 months of age at the start of the RSV season
not receiving palivizumab prophylaxis and not recommended to receive palivizumab according to the AAP guidelines
To estimate the incidence rate of hospitalization attributable to RSV in the other relevant study populations and time periods eg Cohort 2 Cohorts 1 and 2 combined and subgroups based on chronological age at the start of the RSV season GA etc within 150 days from enrollment and other time periods based on RSV activity etc
To estimate the incidence of RSV-associated MALRI in the study populations
To characterize the incidence and type of clinical interventions for MALRI in the study populations
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None