Study to Evaluate the Incidence of Hospitalizations and Respiratory Tract Infections in Premature Infants

Respiratory Syncytial Virus Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00384462
• Other study ID #: MI-MA140
• Status: Completed
• Phase: N/A
• First received: October 4, 2006
• Last updated: February 3, 2009
• Start date: October 2006
• Est. completion date: January 2008

Study information

• Verified date: February 2009
• Source: MedImmune LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 346
• Est. completion date: January 2008
• Est. primary completion date: November 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Month to 6 Months

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Infection
• Respiratory Syncytial Virus Infections
• Respiratory Tract Infections
• Virus Diseases

Locations

Country	Name	City	State
United States	Children's Hospital Medical Center of Akron	Akron	Ohio
United States	Albany Medical Center	Albany	New York
United States	Georgia Pediatric Pulmonology Associates	Atlanta	Georgia
United States	University of Maryland, School of Medicine	Baltimore	Maryland
United States	Central Arkansas Pediatric Clinic, P.A.	Benton	Arkansas
United States	St. Luke's Hospital	Bethlehem	Pennsylvania
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Beehly Medical Park Women's and Children's Pavilion	Boardman	Ohio
United States	Boston Medical Center	Boston	Massachusetts
United States	Tufts-New England Medical Center	Boston	Massachusetts
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	Carolinas Medical Center	Charlotte	North Carolina
United States	Children's Memorial Hospital	Chicago	Illinois
United States	University of Illinois at Chicago	Chicago	Illinois
United States	University of Cincinnati College of Medicine	Cincinnati	Ohio
United States	Metro Health Medical Center	Cleveland	Ohio
United States	Driscoll Children's Hospital	Corpus Christi	Texas
United States	University of Texas Southwestern Medical Center	Dallas	Texas
United States	Geisinger Medical Center - JW Children's Hospital	Danville	Pennsylvania
United States	Children's Medical Center	Dayton	Ohio
United States	Children's Hospital	Denver	Colorado
United States	Duke University Medical Center	Durham	North Carolina
United States	Shands Hospital at the University of Florida	Gainesville	Florida
United States	Raleigh Pediatric Associates	Gardner	North Carolina
United States	Kapiolani Medical Center	Honolulu	Hawaii
United States	University of Texas Houston Medical Center	Houston	Texas
United States	University Physicians Internal Medicine	Huntington	West Virginia
United States	The Children's Clinic of Jonesboro, P.A.	Jonesboro	Arkansas
United States	Pediatric Associates of Dayton, Inc.	Kettering	Ohio
United States	Midwest Children's Health Research Institute, LLC	Lincoln	Nebraska
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	University of Miami Medical Center	Miami	Florida
United States	Winthrop University Hospital	Mineola	New York
United States	West Virginia University	Morgantown	West Virginia
United States	Children's Hospital of Oakland	Oakland	California
United States	Creighton University Medical Center	Omaha	Nebraska
United States	Children's Hospital of Orange County	Orange	California
United States	Pennsylvania Hospital	Philadelphia	Pennsylvania
United States	Children's Hospital of Pittsburgh	Pittsburgh	Pennsylvania
United States	Oregon Health & Science University	Portland	Oregon
United States	Rhode Island Hospital	Providence	Rhode Island
United States	Raleigh Pediatric Associates	Raleigh	North Carolina
United States	VCU Medical Center, Children's Pavillion	Richmond	Virginia
United States	University of Rochester Medical Center	Rochester	New York
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	Children's Healthcare D.B.A. Hospitals & Clinics	St. Paul	Minnesota
United States	Pediatric Pulmonology, LLC	Stamford	Connecticut
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	University of South Florida Pediatrics Ambulatory Care Center	Tampa	Florida
United States	St. Vincent Medical Center	Toledo	Ohio
United States	Children's Hospital Waukesha Memorial	Waukesha	Wisconsin
United States	Children's Corporate Center	Wauwatosa	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
MedImmune LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Estimate the incidence of hospitalization attributable to RSV within 150 days from enrollment in premature infants		150 days from enrollment	No
Secondary	Estimate the incidence rate of hospitalization attributable to RSV in the other relevant study populations		150 days after enrollment	No
Secondary	Estimate the incidence rate of MALRI attributable to RSV in the study populations;		during follow up	No