Children < 2 years old with CLD requiring medical therapy within 6 months of the RSV season are included among those recommended for RSV prophylaxis by the AAP Red Book Guidelines. The Outcomes Registry is a prospective study designed to follow a nationwide sample of children who received palivizumab during the 2003-2004 RSV season and provides an opportunity to evaluate caregiver practices among children with CLD, a high risk population on whom limited data is available.
6087 children from 175 sites who received > 1 dose of palivizumab after June 1, 2003 were enrolled. Demographics, risk factors, injection history, and confirmed RSV-hospitalizations were recorded. Reported medical history of children with CLD was examined to elucidate potential contributing factors for RSV prophylaxis.
Nineteen percent of enrollees reported CLD (n=1155). Eighty percent of children with CLD reported additional respiratory conditions: RAD/asthma/wheezing (52%), apnea (33%), RDS (30%), and CF (0.9%). Non-respiratory conditions reported (other than prematurity) included: Cerebral Palsy(2%), anemia (16%), GERD (32%), and Down Syndrome (0.8%). Children with CLD also reported high incidences of family history of asthma (36%) and atopy/allergy (24%).
Contributing reasons for providing RSV prevention strategies among children with CLD may include concurrent medical conditions including asthma, wheezing, and family history of asthma/allergy. The large scope and broad representation of geographical areas in the collaborative Registry provides an opportunity to monitor “real life” palivizumab utilization and clinical decision making, especially among those with CLD.
Clinical practice reporting in the Registry shows children with CLD have additional medical conditions that may be contributing to reasons for prescribing RSV prophylaxis in this high risk population.
B. McWilliams, MedImmune, Inc.