Study to Evaluate the Incidence of Hospitalizations and Respiratory Tract Infections in Premature Infants
NCT ID: NCT00384462
Last Updated: 2009-02-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
346 participants
OBSERVATIONAL
2006-10-31
2008-01-31
Brief Summary
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Detailed Description
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* To estimate the incidence of hospitalization attributable to RSV within 150 days from enrollment in premature infants who are:
* 32-35 weeks GA
* less than 6 months of age at the start of the RSV season
* not receiving palivizumab prophylaxis and not recommended to receive palivizumab according to the AAP guidelines
* To estimate the incidence rate of hospitalization attributable to RSV in the other relevant study populations and time periods (e.g., Cohort 2, Cohorts 1 and 2 combined, and subgroups based on chronological age at the start of the RSV season, GA, etc. within 150 days from enrollment and other time periods based on RSV activity, etc.)
* To estimate the incidence of RSV-associated MALRI in the study populations
* To characterize the incidence and type of clinical interventions for MALRI in the study populations
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
No interventions assigned to this group
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.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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:
1. Childcare attendance
2. School-aged siblings in the home
3. Exposure to environmental air pollutants (not including passive exposure to tobacco smoke)
4. Congenital abnormalities of the airways
5. 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
* Date of enrollment between 16/Dec and 15/Feb
* Born during the current RSV season and discharged from the hospital nursery after 01/Dec
* 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
Exclusion Criteria
* Hospitalization at the time of enrollment (unless discharge is anticipated within 10 days)
1 Month
6 Months
ALL
No
Sponsors
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MedImmune LLC
INDUSTRY
Responsible Party
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MedImmune Inc.
Principal Investigators
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Frank Malinoski, M.D., PhD
Role: STUDY_DIRECTOR
MedImmune LLC
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Central Arkansas Pediatric Clinic, P.A.
Benton, Arkansas, United States
The Children's Clinic of Jonesboro, P.A.
Jonesboro, Arkansas, United States
Arkansas Children's Hospital Research Institute
Little Rock, Arkansas, United States
Arkansas Pediatric Clinic
Little Rock, Arkansas, United States
Little Rock Children's Clinic
Little Rock, Arkansas, United States
Miller Children's Hospital
Long Beach, California, United States
Children's Hospital of Oakland
Oakland, California, United States
Children's Hospital of Orange County
Orange, California, United States
Children's Hospital
Denver, Colorado, United States
Pediatric Pulmonology, LLC
Stamford, Connecticut, United States
Shands Hospital at the University of Florida
Gainesville, Florida, United States
University of Miami Medical Center
Miami, Florida, United States
University of South Florida Pediatrics Ambulatory Care Center
Tampa, Florida, United States
Georgia Pediatric Pulmonology Associates
Atlanta, Georgia, United States
Kapiolani Medical Center
Honolulu, Hawaii, United States
University of Illinois at Chicago
Chicago, Illinois, United States
Children's Memorial Hospital
Chicago, Illinois, United States
Memorial Hospital of South Bend
South Bend, Indiana, United States
University of Maryland, School of Medicine
Baltimore, Maryland, United States
Tufts-New England Medical Center
Boston, Massachusetts, United States
Boston Medical Center
Boston, Massachusetts, United States
Children's Healthcare D.B.A. Hospitals & Clinics
Saint Paul, Minnesota, United States
Pediatrix Medical Group, St. John's Mercy Medical Center
St Louis, Missouri, United States
Midwest Children's Health Research Institute, LLC
Lincoln, Nebraska, United States
Creighton University Medical Center
Omaha, Nebraska, United States
Albany Medical Center
Albany, New York, United States
Winthrop University Hospital
Mineola, New York, United States
University of Rochester Medical Center
Rochester, New York, United States
University Hospital, State University of New York at Stony Brook
Stony Brook, New York, United States
Crouse Hospital NICU
Syracuse, New York, United States
Bronx-Lebanon Hospital Center
The Bronx, New York, United States
Jacobi Medical Center
The Bronx, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
Carolinas Medical Center
Charlotte, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
Raleigh Pediatric Associates
Gardner, North Carolina, United States
Raleigh Pediatric Associates
Raleigh, North Carolina, United States
Children's Hospital Medical Center of Akron
Akron, Ohio, United States
Beehly Medical Park Women's and Children's Pavilion
Boardman, Ohio, United States
University of Cincinnati College of Medicine
Cincinnati, Ohio, United States
Metro Health Medical Center
Cleveland, Ohio, United States
Children's Medical Center
Dayton, Ohio, United States
Pediatric Associates of Dayton, Inc.
Kettering, Ohio, United States
St. Vincent Medical Center
Toledo, Ohio, United States
Oregon Health & Science University
Portland, Oregon, United States
St. Luke's Hospital
Bethlehem, Pennsylvania, United States
Geisinger Medical Center - JW Children's Hospital
Danville, Pennsylvania, United States
Pennsylvania Hospital
Philadelphia, Pennsylvania, United States
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States
Rhode Island Hospital
Providence, Rhode Island, United States
Driscoll Children's Hospital
Corpus Christi, Texas, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
University of Texas Houston Medical Center
Houston, Texas, United States
VCU Medical Center, Children's Pavillion
Richmond, Virginia, United States
University Physicians Internal Medicine
Huntington, West Virginia, United States
West Virginia University
Morgantown, West Virginia, United States
Children's Hospital Waukesha Memorial
Waukesha, Wisconsin, United States
Children's Corporate Center
Wauwatosa, Wisconsin, United States
Countries
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Other Identifiers
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MI-MA140
Identifier Type: -
Identifier Source: org_study_id
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