Study to Evaluate the Incidence of Hospitalizations and Respiratory Tract Infections in Premature Infants
A Prospective, Non-Interventional Study to Evaluate the Incidence of Hospitalizations and Medically-Attended Lower Respiratory Tract Infection (MALRI) in Premature Infants 32 to 35 Weeks Gestational Age Who Are Not Recommended to Receive Prophylaxis for RSV
1 other identifier
observational
346
1 country
59
Brief Summary
The purpose of this study is to describe respiratory syncytial virus (RSV) hospitalization rates and to begin to address the utilization of outpatient resources for RSV medically-attended lower respiratory tract infections (MALRI) in 32-35 week gestational age (GA) premature infants who are less than 6 months of age and do not receive treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2006
59 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2006
CompletedFirst Submitted
Initial submission to the registry
October 4, 2006
CompletedFirst Posted
Study publicly available on registry
October 6, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2008
CompletedFebruary 4, 2009
February 1, 2009
1.1 years
October 4, 2006
February 3, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Estimate the incidence of hospitalization attributable to RSV within 150 days from enrollment in premature infants
150 days from enrollment
Secondary Outcomes (2)
Estimate the incidence rate of hospitalization attributable to RSV in the other relevant study populations
150 days after enrollment
Estimate the incidence rate of MALRI attributable to RSV in the study populations;
during follow up
Study Arms (2)
1
Premature Infants (32-35 wks. GA) who are less than six months of age at start of RSV season and followed until May of the following year.
2
Premature newborns (32-35 wks. GA) who are born during the current RSV season and discharged from the hospital after 01 Dec and followed until May of the next year.
Eligibility Criteria
2 cohorts of premature infants and premature newborns 32-35 weeks
You may qualify if:
- Parent/legal guardian able to understand and provide written informed consent
- Male or female infants born at 32-35 weeks GA. GA will be determined according to available medical records.
- Clinically stable, in the opinion of the investigator
- Ability and willingness of the subject's parent/legal guardian to complete all protocol mandated follow-up telephone calls, visits and procedures
- Not more than one of the following American Academy of Pediatrics (AAP)-defined risk factors:
- Childcare attendance
- School-aged siblings in the home
- Exposure to environmental air pollutants (not including passive exposure to tobacco smoke)
- Congenital abnormalities of the airways
- Severe neuromuscular disease, as determined by the investigator
- Subject must meet the criteria listed below for either Cohort 1 or Cohort 2:
- Cohort 1
- Date of enrollment between 01/Oct and 15/Dec
- Chronological age of \< 6 months (i.e., has not yet reached 6-month birthday) at the traditional start of the local RSV season (as used to determine eligibility for RSV prophylaxis)
- Cohort 2
- +2 more criteria
You may not qualify if:
- Previous (within 90 days of enrollment) or concurrent treatment with palivizumab or RSV-IGIV or IVIG
- Hospitalization at the time of enrollment (unless discharge is anticipated within 10 days)
- Participation in trials of investigational RSV prophylaxis or therapeutic agents
- Confirmed prior or current RSV infection (a child with current signs/symptoms of respiratory infection must have negative RSV testing)
- Diagnosis of chronic lung disease (CLD) of prematurity (formerly referred to as bronchopulmonary dysplasia \[BPD\])
- Diagnosis of hemodynamically significant congenital heart disease (CHD), defined as requiring medication or supplemental oxygen for their CHD
- Known immunodeficiency
- Life expectancy of \< 6 months
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- MedImmune LLClead
Study Sites (59)
University of Alabama at Birmingham
Birmingham, Alabama, 35233, United States
Central Arkansas Pediatric Clinic, P.A.
Benton, Arkansas, 72019, United States
The Children's Clinic of Jonesboro, P.A.
Jonesboro, Arkansas, 72401, United States
Arkansas Children's Hospital Research Institute
Little Rock, Arkansas, 72205, United States
Arkansas Pediatric Clinic
Little Rock, Arkansas, 72205, United States
Little Rock Children's Clinic
Little Rock, Arkansas, 72205, United States
Miller Children's Hospital
Long Beach, California, 90806, United States
Children's Hospital of Oakland
Oakland, California, 94609, United States
Children's Hospital of Orange County
Orange, California, 92868, United States
Children's Hospital
Denver, Colorado, 82018, United States
Pediatric Pulmonology, LLC
Stamford, Connecticut, 06902, United States
Shands Hospital at the University of Florida
Gainesville, Florida, 32610, United States
University of Miami Medical Center
Miami, Florida, 33136, United States
University of South Florida Pediatrics Ambulatory Care Center
Tampa, Florida, 33136, United States
Georgia Pediatric Pulmonology Associates
Atlanta, Georgia, 30342, United States
Kapiolani Medical Center
Honolulu, Hawaii, 96826, United States
University of Illinois at Chicago
Chicago, Illinois, 60612, United States
Children's Memorial Hospital
Chicago, Illinois, 60614, United States
Memorial Hospital of South Bend
South Bend, Indiana, 46601, United States
University of Maryland, School of Medicine
Baltimore, Maryland, 21201, United States
Tufts-New England Medical Center
Boston, Massachusetts, 02111, United States
Boston Medical Center
Boston, Massachusetts, 02118, United States
Children's Healthcare D.B.A. Hospitals & Clinics
Saint Paul, Minnesota, 55102, United States
Pediatrix Medical Group, St. John's Mercy Medical Center
St Louis, Missouri, 63141, United States
Midwest Children's Health Research Institute, LLC
Lincoln, Nebraska, 68505, United States
Creighton University Medical Center
Omaha, Nebraska, 68198, United States
Albany Medical Center
Albany, New York, 12208, United States
Winthrop University Hospital
Mineola, New York, 11501, United States
University of Rochester Medical Center
Rochester, New York, 14624, United States
University Hospital, State University of New York at Stony Brook
Stony Brook, New York, 11794, United States
Crouse Hospital NICU
Syracuse, New York, 13210, United States
Bronx-Lebanon Hospital Center
The Bronx, New York, 10457, United States
Jacobi Medical Center
The Bronx, New York, 10461, United States
Montefiore Medical Center
The Bronx, New York, 10467, United States
Carolinas Medical Center
Charlotte, North Carolina, 28203, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Raleigh Pediatric Associates
Gardner, North Carolina, 27529, United States
Raleigh Pediatric Associates
Raleigh, North Carolina, 27615, United States
Children's Hospital Medical Center of Akron
Akron, Ohio, 44308, United States
Beehly Medical Park Women's and Children's Pavilion
Boardman, Ohio, 44512, United States
University of Cincinnati College of Medicine
Cincinnati, Ohio, 45267, United States
Metro Health Medical Center
Cleveland, Ohio, 44109, United States
Children's Medical Center
Dayton, Ohio, 45404, United States
Pediatric Associates of Dayton, Inc.
Kettering, Ohio, 45429, United States
St. Vincent Medical Center
Toledo, Ohio, 43608, United States
Oregon Health & Science University
Portland, Oregon, 97239, United States
St. Luke's Hospital
Bethlehem, Pennsylvania, 18015, United States
Geisinger Medical Center - JW Children's Hospital
Danville, Pennsylvania, 17822, United States
Pennsylvania Hospital
Philadelphia, Pennsylvania, 19017, United States
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15213, United States
Rhode Island Hospital
Providence, Rhode Island, 02903, United States
Driscoll Children's Hospital
Corpus Christi, Texas, 78414, United States
University of Texas Southwestern Medical Center
Dallas, Texas, 75390, United States
University of Texas Houston Medical Center
Houston, Texas, 77030, United States
VCU Medical Center, Children's Pavillion
Richmond, Virginia, 23298, United States
University Physicians Internal Medicine
Huntington, West Virginia, 25701, United States
West Virginia University
Morgantown, West Virginia, 26506, United States
Children's Hospital Waukesha Memorial
Waukesha, Wisconsin, 53118, United States
Children's Corporate Center
Wauwatosa, Wisconsin, 53226, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Frank Malinoski, M.D., PhD
MedImmune LLC
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 4, 2006
First Posted
October 6, 2006
Study Start
October 1, 2006
Primary Completion
November 1, 2007
Study Completion
January 1, 2008
Last Updated
February 4, 2009
Record last verified: 2009-02