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

Completed

Conditions studied: Respiratory Syncytial Virus Infections

In brief

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.

Key facts

Study ID

NCT00384462

Run by

MedImmune LLC

People needed

346

Starts

2006-10-01

Expected to finish

2008-01-01

Last updated by the study team

2009-02-04

Who can join

Age: 0 and older, up to 1. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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
• University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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