Respiratory Events Among Premature Infants

Completed

• Conditions: Respiratory Syncytial Virus

• Registration Number: NCT00889070
• Lead Sponsor: MedImmune LLC

Brief Summary

Assess the burden of disease associated with RSV infection with premature children in an outpatient setting.

Detailed Description

The primary objective of this prospective study is to assess the burden of disease associated with RSV infection, as measured/determined by rates of outpatient medically attended LRI, emergency room visits and hospitalization among preterm infants (32-≤36 wGA) during RSV season, and its medical/health consequences, as measured by wheezing events, the infant's first RSV season, up to May 2009.

Study Timeline

• Study Start: 2008-11
• Study First Submitted: 2009-04-24
• Study First Submitted QC: 2009-04-24
• Study First Posted: 2009-04-28
• Primary Completion: 2009-05
• Study Completion: 2009-05
• Status Verified: 2009-08
• Last Update Submitted: 2009-08-06
• Last Update Posted: 2009-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Written informed consent from parent/guardian to participate in study
• Male or female preterm infants 32-≤36 wGA
• Infant is ≤ 6month old at the time of enrollment
• Parent/guardian has the ability and willingness to follow study protocol (during the first RSV season) as required by the protocol

Exclusion Criteria

• Receipt of any RSV prophylactic agent: palivizumab, IGIV, or motavizumab at any time prior to enrollment
• Participation in trials of investigational RSV prophylaxis or RSV therapeutic agents
• Presence of BPD or CHD (other than surgically treated PDA, ASD or VSD)
• Condition that limits life span to 6 months or less from the date of enrollment

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The rate of RSV positivity and rate of outpatient and/or inpatient LRI events as well as the rate of outpatient and inpatient wheezing events.	Seasonal: 2008-09

Secondary Outcome Measures

Name	Time	Method
Evaluate characteristics of infants in RSV risk factor and rate and reason of attrition.	Seasonal: 2008-09

Trial Locations

Locations (5)

Suny Upstate Medical University; 🇺🇸 Syracuse, New York, United States

Children's Primary Care Medical Group, Inc.; 🇺🇸 San Diego, California, United States

Senders Pediatrics; 🇺🇸 Cleveland, Ohio, United States

North Florida Pediatrics; 🇺🇸 Lake City, Florida, United States

Woburn Pediatric Associates; 🇺🇸 Woburn, Massachusetts, United States