Respiratory Events Among Premature Infants

Completed

Conditions studied: Respiratory Syncytial Virus

In brief

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

Key facts

Study ID

NCT00889070

Run by

MedImmune LLC

People needed

50

Starts

2008-11-01

Expected to finish

2009-05-01

Last updated by the study team

2009-08-07

Who can join

Age: any, up to 1. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Children's Primary Care Medical Group, Inc. — San Diego, California, United States
• North Florida Pediatrics — Lake City, Florida, United States
• Woburn Pediatric Associates — Woburn, Massachusetts, United States
• Suny Upstate Medical University — Syracuse, New York, United States
• Senders Pediatrics — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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