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Intravenous Injections in Neonatal Mice
Published on: November 11, 2014
Administration of Palivizumab in the NICU
Neika Vendetti1, Jeffrey S Gerber2, Julia Shaklee Sammons3
1Division of Infectious Diseases and Center for Pediatric Clinical Effectiveness, and Merck & Co., Blue Bell, Pennsylvania;
Insights
Despite guidelines, palivizumab (NDP) was frequently used for infants to prevent health care-associated respiratory syncytial virus (HA-RSV), even in low-risk infants. This practice occurred despite recommendations against its use for HA-RSV prevention.
Area of Science:
- Pediatric Infectious Diseases
- Hospital Epidemiology
- Pharmacovigilance
Background:
- The American Academy of Pediatrics advises palivizumab for high-risk infants to prevent community-acquired respiratory syncytial virus (RSV).
- Current guidelines do not support palivizumab use for preventing health care-associated RSV (HA-RSV).
Purpose of the Study:
- To investigate the utilization of nondischarge palivizumab (NDP) in hospitalized infants.
- To assess the frequency of HA-RSV in infants who received NDP versus those who did not.
- To examine NDP use patterns in both high-risk and low-risk infant populations.
Main Methods:
- Retrospective, multicenter cohort study of 1263 infants receiving NDP between 2009 and 2013.
- NDP defined as palivizumab administration more than 7 days before hospital discharge.
- HA-RSV identified by positive RSV test >3 days post-admission; NDP use compared between HA-RSV cases and controls.
Main Results:
- Most NDP recipients (80%) were classified as high-risk; however, 12% of low-risk infants also received NDP.
- NDP use varied significantly across institutions.
- Of 25 infants who developed HA-RSV, 17 had received NDP, indicating common use despite guidelines.
Conclusions:
- Palivizumab prophylaxis for HA-RSV prevention was prevalent, contradicting established recommendations.
- The study highlights off-label use of palivizumab, even in low-risk infants, suggesting a need for guideline reinforcement.
Background:
The American Academy of Pediatrics recommends palivizumab prophylaxis against respiratory syncytial virus (RSV) for infants at high risk for severe disease within 72 hours of hospital discharge to prevent community-associated RSV. The American Academy of Pediatrics does not recommend palivizumab to prevent health care-associated RSV (HA-RSV).
Methods:
A retrospective, multicenter cohort of hospitalized infants who received nondischarge palivizumab (NDP) between January 2009 and December 2013 was established from 14 hospitals. NDP was defined as a charge for palivizumab >7 days before hospital discharge and no previous documented RSV. Infants were considered high risk for severe disease if they had chronic lung disease, chronic heart disease, or prematurity. Nondischarge palivizumab use was examined for high- and low-risk infants. HA-RSV was defined as an RSV-positive test (polymerase chain reaction, enzyme immunoassays, or culture) >3 days after admission and the frequency was measured for infants who did and did not receive NDP.
Results:
We identified 1263 patients who received at least 1 dose of NDP, most of whom were classified as high risk (80%). Among high-risk patients, the predictors of receipt of NDP included longer length of stay, institution, and no comorbid conditions. Most of the low-risk patients (88%) who received NDP had no comorbid conditions. NDP use varied widely among institutions. Overall, 25 eligible patients developed HA-RSV; 17 of whom received NDP.
Conclusions:
Despite current recommendations, palivizumab for prevention of HA-RSV was common, even among patients at low risk of severe RSV.
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