Status:
COMPLETED
Study to Evaluate the Incidence of Hospitalizations and Respiratory Tract Infections in Premature Infants
Lead Sponsor:
MedImmune LLC
Conditions:
Respiratory Syncytial Virus Infections
Eligibility:
All Genders
1-6 years
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 respir...
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 month...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
October 1 2006
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 1 2008
Estimated Enrollment :
346 Patients enrolled
Trial Details
Trial ID
NCT00384462
Start Date
October 1 2006
End Date
January 1 2008
Last Update
February 4 2009
Active Locations (59)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
2
Central Arkansas Pediatric Clinic, P.A.
Benton, Arkansas, United States, 72019
3
The Children's Clinic of Jonesboro, P.A.
Jonesboro, Arkansas, United States, 72401
4
Arkansas Children's Hospital Research Institute
Little Rock, Arkansas, United States, 72205