Respiratory Events Among Premature Infants

This study has been completed.
Sponsor:
Information provided by:
MedImmune LLC
ClinicalTrials.gov Identifier:
NCT00889070
First received: April 24, 2009
Last updated: August 6, 2009
Last verified: August 2009
  Purpose

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


Condition
Respiratory Syncytial Virus

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Respiratory Events Among Premature Infants (32-<36 w/GA) - Outcomes & Risk Tracking Study (The REPORT Study)

Further study details as provided by MedImmune LLC:

Primary Outcome Measures:
  • 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. [ Time Frame: Seasonal: 2008-09 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Evaluate characteristics of infants in RSV risk factor and rate and reason of attrition. [ Time Frame: Seasonal: 2008-09 ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: November 2008
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Stage 1 (Pilot Study) All infants enrolled in the pilot stage and completing baseline screening will be evaluated as the analyzable set.

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.

  Eligibility

Ages Eligible for Study:   up to 6 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Male or female preterm infants 32-≤36 wGA

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00889070

Locations
United States, California
Children's Primary Care Medical Group, Inc.
San Diego, California, United States, 92120
United States, Florida
North Florida Pediatrics
Lake City, Florida, United States, 32025
United States, Massachusetts
Woburn Pediatric Associates
Woburn, Massachusetts, United States, 18013
United States, New York
Suny Upstate Medical University
Syracuse, New York, United States, 13120
United States, Ohio
Senders Pediatrics
Cleveland, Ohio, United States, 44421
Sponsors and Collaborators
MedImmune LLC
Investigators
Study Director: Hanaa Elhefni, MD, MS, MPH MedImmune LLC
  More Information

No publications provided

Responsible Party: Hanaa Elhefni, MD, MS, MPH, MedImmune LLC
ClinicalTrials.gov Identifier: NCT00889070     History of Changes
Other Study ID Numbers: MI-MA192
Study First Received: April 24, 2009
Last Updated: August 6, 2009
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on October 29, 2014