MedImmune funds study on RSV disease among premature infants

MedImmune continues to advance its commitment to pediatric research with today's announcement of the first observational prospective study designed to assess the burden of respiratory syncytial virus (RSV) among preterm infants 32-to-35 weeks gestational age (GA) in outpatient settings during their first year of life.

The study also seeks to gather virology data regarding the national onset of the RSV season across the four geographic regions established by the U.S. Centers for Disease Control & Prevention. Additionally, this two-year observational study will look to identify the preterm infants that may be most susceptible to serious RSV infection and the factors that may elevate that risk.

"More than 98 percent of all children contract RSV before their second birthday. Some of these children will be hospitalized and for many more, the severity of the infection forces them to visit a healthcare provider or hospital clinic on an outpatient basis," said Jessie Groothuis, M.D., MedImmune vice president, medical and scientific affairs, infectious disease. "The intent of this first-of-its-kind prospective study is to add to the body of evidence surrounding RSV burden of disease; gaining a snapshot of when the RSV season starts and stops; as well as gathering insight into what risk factors may make preterm infants most susceptible to RSV infection and to serious RSV-related illness."

She went on to say that this information may help pediatricians, payers and health policy makers make better decisions regarding the use of finite healthcare resources on behalf of under-represented and under-served 32-to-35 weeks (GA) preterm infants.

This observational, prospective study will cover two consecutive RSV seasons and begin patient enrollment in fall 2009, with a target of 3,000 participants across 100 outpatient sites in the United States. The study population will include infants born 32-to-35 weeks (GA) who do not receive RSV prophylaxis during their first RSV season.

Each year, up to 125,000 infants in the United States are hospitalized with severe RSV infections, the leading cause of lower respiratory tract infections in U.S. infants. RSV is the most common respiratory infection in infancy or childhood. Approximately one-half of all infants are infected with RSV during the first year of life, and nearly all children have been infected at least once by the time they reach their second birthday. Children born prematurely as well as those with chronic lung disease (CLD) or congenital heart disease (CHD) are at highest risk for severe disease and hospitalization due to RSV. The virus may also cause severe illness in other high-risk groups.

A recent study published in the New England Journal of Medicine found that RSV accounts for one of every 13 visits to a pediatrician, one of every 38 emergency room trips, and inpatient hospital stays for one out of every 334 children.