Respiratory Events Among Premature Infants

Respiratory Syncytial Virus Clinical Trial

Official title:

Respiratory Events Among Premature Infants (32-<36 w/GA) - Outcomes & Risk Tracking Study (The REPORT Study)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00889070
• Other study ID #: MI-MA192
• Status: Completed
• Phase: N/A
• First received: April 24, 2009
• Last updated: August 6, 2009
• Start date: November 2008
• Est. completion date: May 2009

Study information

• Verified date: August 2009
• Source: MedImmune LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: May 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 6 Months

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Respiratory Syncytial Virus

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
MedImmune LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Evaluate characteristics of infants in RSV risk factor and rate and reason of attrition.		Seasonal: 2008-09	No