Study to Evaluate the Incidence of Hospitalizations and Respiratory Tract Infections in Premature Infants
- Conditions
- Respiratory Syncytial Virus Infections
- Registration Number
- NCT00384462
- Lead Sponsor
- MedImmune LLC
- 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.
- Detailed Description
The goals of this study are:
* 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 346
-
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
- Date of enrollment between 16/Dec and 15/Feb
- Born during the current RSV season and discharged from the hospital nursery after 01/Dec
- 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)
- Two or more AAP-defined risk factors as listed under Inclusion Criteria
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Estimate the incidence of hospitalization attributable to RSV within 150 days from enrollment in premature infants 150 days from enrollment
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (58)
Pediatric Associates of Dayton, Inc.
🇺🇸Kettering, Ohio, United States
Driscoll Children's Hospital
🇺🇸Corpus Christi, Texas, United States
Georgia Pediatric Pulmonology Associates
🇺🇸Atlanta, Georgia, United States
Little Rock Children's Clinic
🇺🇸Little Rock, Arkansas, United States
Arkansas Pediatric Clinic
🇺🇸Little Rock, Arkansas, United States
Children's Hospital of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States
Raleigh Pediatric Associates
🇺🇸Raleigh, North Carolina, United States
Tufts-New England Medical Center
🇺🇸Boston, Massachusetts, United States
University of Miami Medical Center
🇺🇸Miami, Florida, United States
Children's Memorial Hospital
🇺🇸Chicago, Illinois, United States
University of Maryland, School of Medicine
🇺🇸Baltimore, Maryland, United States
University Hospital, State University of New York at Stony Brook
🇺🇸Stony Brook, New York, United States
Carolinas Medical Center
🇺🇸Charlotte, North Carolina, United States
Geisinger Medical Center - JW Children's Hospital
🇺🇸Danville, Pennsylvania, United States
Pennsylvania Hospital
🇺🇸Philadelphia, Pennsylvania, United States
Kapiolani Medical Center
🇺🇸Honolulu, Hawaii, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
University of Cincinnati College of Medicine
🇺🇸Cincinnati, Ohio, United States
Crouse Hospital NICU
🇺🇸Syracuse, New York, United States
Children's Hospital Medical Center of Akron
🇺🇸Akron, Ohio, United States
Children's Medical Center
🇺🇸Dayton, Ohio, United States
St. Vincent Medical Center
🇺🇸Toledo, Ohio, United States
Metro Health Medical Center
🇺🇸Cleveland, Ohio, United States
Beehly Medical Park Women's and Children's Pavilion
🇺🇸Boardman, Ohio, United States
St. Luke's Hospital
🇺🇸Bethlehem, Pennsylvania, United States
University of Texas Southwestern Medical Center
🇺🇸Dallas, Texas, United States
University of Texas Houston Medical Center
🇺🇸Houston, Texas, United States
Miller Children's Hospital
🇺🇸Long Beach, California, United States
Children's Hospital of Oakland
🇺🇸Oakland, California, United States
University of Illinois at Chicago
🇺🇸Chicago, Illinois, United States
Memorial Hospital of South Bend
🇺🇸South Bend, Indiana, United States
Pediatrix Medical Group, St. John's Mercy Medical Center
🇺🇸St. Louis, Missouri, United States
Albany Medical Center
🇺🇸Albany, New York, United States
Winthrop University Hospital
🇺🇸Mineola, New York, United States
Children's Healthcare D.B.A. Hospitals & Clinics
🇺🇸St. Paul, Minnesota, United States
Boston Medical Center
🇺🇸Boston, Massachusetts, United States
University of Rochester Medical Center
🇺🇸Rochester, New York, United States
Children's Hospital of Orange County
🇺🇸Orange, California, United States
Central Arkansas Pediatric Clinic, P.A.
🇺🇸Benton, Arkansas, United States
Midwest Children's Health Research Institute, LLC
🇺🇸Lincoln, Nebraska, United States
Children's Hospital Waukesha Memorial
🇺🇸Waukesha, Wisconsin, United States
Arkansas Children's Hospital Research Institute
🇺🇸Little Rock, Arkansas, United States
Children's Corporate Center
🇺🇸Wauwatosa, Wisconsin, United States
The Children's Clinic of Jonesboro, P.A.
🇺🇸Jonesboro, Arkansas, United States
Pediatric Pulmonology, LLC
🇺🇸Stamford, Connecticut, United States
University Physicians Internal Medicine
🇺🇸Huntington, West Virginia, United States
Oregon Health & Science University
🇺🇸Portland, Oregon, United States
West Virginia University
🇺🇸Morgantown, West Virginia, United States
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Children's Hospital
🇺🇸Denver, Colorado, United States
Creighton University Medical Center
🇺🇸Omaha, Nebraska, United States
University of South Florida Pediatrics Ambulatory Care Center
🇺🇸Tampa, Florida, United States
VCU Medical Center, Children's Pavillion
🇺🇸Richmond, Virginia, United States
Shands Hospital at the University of Florida
🇺🇸Gainesville, Florida, United States
Bronx-Lebanon Hospital Center
🇺🇸Bronx, New York, United States
Jacobi Medical Center
🇺🇸Bronx, New York, United States
Montefiore Medical Center
🇺🇸Bronx, New York, United States
Rhode Island Hospital
🇺🇸Providence, Rhode Island, United States