Clinical trial NCT00384462: Study to Evaluate the Incidence of Hospitalizations and Respiratory Tract Infections in Premature Infants
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Respiratory Syncytial Virus Infections
Keywords: Premature infants (32-35 weeks GA) <6 months of age at the start of the RSV season who are not receiving palivizumab and do not have CLD of prematurity
Respiratory Syncytial Viruses
Lead sponsor: MedImmune LLC
Sponsor class: INDUSTRY
First posted: 2006-10-06
Enrollment: 346
Sex: ALL
Minimum age (years): 1
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 2 cohorts of premature infants and premature newborns 32-35 weeks

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

Eligibility criteria: Inclusion Criteria:

* 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:

  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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Estimate the incidence of hospitalization attributable to RSV within 150 days from enrollment in premature infants
timeFrame: 150 days from enrollment
Secondary outcomes:
measure: Estimate the incidence rate of hospitalization attributable to RSV in the other relevant study populations
timeFrame: 150 days after enrollment
measure: Estimate the incidence rate of MALRI attributable to RSV in the study populations;
timeFrame: during follow up
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Benton
country: United States
facility: Central Arkansas Pediatric Clinic, P.A.
state: Arkansas
city: Jonesboro
country: United States
facility: The Children's Clinic of Jonesboro, P.A.
state: Arkansas
city: Little Rock
country: United States
facility: Arkansas Children's Hospital Research Institute
state: Arkansas
city: Little Rock
country: United States
facility: Arkansas Pediatric Clinic
state: Arkansas
city: Little Rock
country: United States
facility: Little Rock Children's Clinic
state: Arkansas
city: Long Beach
country: United States
facility: Miller Children's Hospital
state: California
city: Oakland
country: United States
facility: Children's Hospital of Oakland
state: California
city: Orange
country: United States
facility: Children's Hospital of Orange County
state: California
city: Denver
country: United States
facility: Children's Hospital
state: Colorado
city: Stamford
country: United States
facility: Pediatric Pulmonology, LLC
state: Connecticut
city: Gainesville
country: United States
facility: Shands Hospital at the University of Florida
state: Florida
city: Miami
country: United States
facility: University of Miami Medical Center
state: Florida
city: Tampa
country: United States
facility: University of South Florida Pediatrics Ambulatory Care Center
state: Florida
city: Atlanta
country: United States
facility: Georgia Pediatric Pulmonology Associates
state: Georgia
city: Honolulu
country: United States
facility: Kapiolani Medical Center
state: Hawaii
city: Chicago
country: United States
facility: University of Illinois at Chicago
state: Illinois
city: Chicago
country: United States
facility: Children's Memorial Hospital
state: Illinois
city: South Bend
country: United States
facility: Memorial Hospital of South Bend
state: Indiana
city: Baltimore
country: United States
facility: University of Maryland, School of Medicine
state: Maryland
city: Boston
country: United States
facility: Tufts-New England Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
city: St. Paul
country: United States
facility: Children's Healthcare D.B.A. Hospitals & Clinics
state: Minnesota
city: St. Louis
country: United States
facility: Pediatrix Medical Group, St. John's Mercy Medical Center
state: Missouri
city: Lincoln
country: United States
facility: Midwest Children's Health Research Institute, LLC
state: Nebraska
city: Omaha
country: United States
facility: Creighton University Medical Center
state: Nebraska
city: Albany
country: United States
facility: Albany Medical Center
state: New York
city: Bronx
country: United States
facility: Bronx-Lebanon Hospital Center
state: New York
city: Bronx
country: United States
facility: Jacobi Medical Center
state: New York
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Mineola
country: United States
facility: Winthrop University Hospital
state: New York
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
city: Stony Brook
country: United States
facility: University Hospital, State University of New York at Stony Brook
state: New York
city: Syracuse
country: United States
facility: Crouse Hospital NICU
state: New York
city: Charlotte
country: United States
facility: Carolinas Medical Center
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Gardner
country: United States
facility: Raleigh Pediatric Associates
state: North Carolina
city: Raleigh
country: United States
facility: Raleigh Pediatric Associates
state: North Carolina
city: Akron
country: United States
facility: Children's Hospital Medical Center of Akron
state: Ohio
city: Boardman
country: United States
facility: Beehly Medical Park Women's and Children's Pavilion
state: Ohio
city: Cincinnati
country: United States
facility: University of Cincinnati College of Medicine
state: Ohio
city: Cleveland
country: United States
facility: Metro Health Medical Center
state: Ohio
city: Dayton
country: United States
facility: Children's Medical Center
state: Ohio
city: Kettering
country: United States
facility: Pediatric Associates of Dayton, Inc.
state: Ohio
city: Toledo
country: United States
facility: St. Vincent Medical Center
state: Ohio
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Bethlehem
country: United States
facility: St. Luke's Hospital
state: Pennsylvania
city: Danville
country: United States
facility: Geisinger Medical Center - JW Children's Hospital
state: Pennsylvania
city: Philadelphia
country: United States
facility: Pennsylvania Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Children's Hospital of Pittsburgh
state: Pennsylvania
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
city: Corpus Christi
country: United States
facility: Driscoll Children's Hospital
state: Texas
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
city: Houston
country: United States
facility: University of Texas Houston Medical Center
state: Texas
city: Richmond
country: United States
facility: VCU Medical Center, Children's Pavillion
state: Virginia
city: Huntington
country: United States
facility: University Physicians Internal Medicine
state: West Virginia
city: Morgantown
country: United States
facility: West Virginia University
state: West Virginia
city: Waukesha
country: United States
facility: Children's Hospital Waukesha Memorial
state: Wisconsin
city: Wauwatosa
country: United States
facility: Children's Corporate Center
state: Wisconsin
Study officials:
affiliation: MedImmune LLC
name: Frank Malinoski, M.D., PhD
role: STUDY_DIRECTOR
References: