Respiratory Events Among Premature Infants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00889070
Recruitment Status : Completed
First Posted : April 28, 2009
Last Update Posted : August 7, 2009
Information provided by:
MedImmune LLC

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

Condition or disease
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
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Respiratory Events Among Premature Infants (32-<36 w/GA) - Outcomes & Risk Tracking Study (The REPORT Study)
Study Start Date : November 2008
Actual Primary Completion Date : May 2009
Actual Study Completion Date : May 2009

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

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Evaluate characteristics of infants in RSV risk factor and rate and reason of attrition. [ Time Frame: Seasonal: 2008-09 ]

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Ages Eligible for Study:   up to 6 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Male or female preterm infants 32-≤36 wGA

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00889070

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
Study Director: Hanaa Elhefni, MD, MS, MPH MedImmune LLC

Responsible Party: Hanaa Elhefni, MD, MS, MPH, MedImmune LLC Identifier: NCT00889070     History of Changes
Other Study ID Numbers: MI-MA192
First Posted: April 28, 2009    Key Record Dates
Last Update Posted: August 7, 2009
Last Verified: August 2009