Respiratory Events Among Premature Infants

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

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

Study Overview

• Status: Completed
• Conditions: Respiratory Syncytial Virus

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 Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92120
      • Children's Primary Care Medical Group, Inc.
  • Florida
    • Lake City, Florida, United States, 32025
      • North Florida Pediatrics
  • Massachusetts
    • Woburn, Massachusetts, United States, 18013
      • Woburn Pediatric Associates
  • New York
    • Syracuse, New York, United States, 13120
      • SUNY Upstate Medical University
  • Ohio
    • Cleveland, Ohio, United States, 44421
      • Senders Pediatrics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 6 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Male or female preterm infants 32-≤36 wGA

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
1; Stage 1 (Pilot Study) All infants enrolled in the pilot stage and completing baseline screening will be evaluated as the analyzable set.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
Evaluate characteristics of infants in RSV risk factor and rate and reason of attrition.	Seasonal: 2008-09

Collaborators and Investigators

• Sponsor: MedImmune LLC
• Investigators: Study Director: Hanaa Elhefni, MD, MS, MPH, MedImmune LLC

Study record dates

Study Major Dates

• Study Start: November 1, 2008
• Primary Completion (Actual): May 1, 2009
• Study Completion (Actual): May 1, 2009

Study Registration Dates

• First Submitted: April 24, 2009
• First Submitted That Met QC Criteria: April 24, 2009
• First Posted (Estimate): April 28, 2009

Study Record Updates

• Last Update Posted (Estimate): August 7, 2009
• Last Update Submitted That Met QC Criteria: August 6, 2009
• Last Verified: August 1, 2009

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Premature Birth
• Other Study ID Numbers: MI-MA192