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Comparing First- and Second-year Palivizumab Prophylaxis in Patients With Hemodynamically Significant Congenital Heart Disease in the CARESS Database (2005–2015)

Li, Abby MSc*; Wang, Daniel Y.*; Lanctôt, Krista L. PhD*; Mitchell, Ian FRCPC; Paes, Bosco A. FRCPC; for the CARESS Investigators

Pediatric Infectious Disease Journal: May 2017 - Volume 36 - Issue 5 - p 445–450
doi: 10.1097/INF.0000000000001357
Original Studies

Background: Respiratory syncytial virus hospitalization (RSVH) rates in children <2 years of age with hemodynamically significant congenital heart disease (HSCHD) are 2- to 4-fold higher compared with healthy term infants. Pediatric recommendations differ as to whether palivizumab is beneficial beyond 1 year of age. The objective of this study was to determine whether differences exist in respiratory-related illness hospitalization (RIH) and RSVH in HSCHD infants receiving palivizumab during the first year versus second year of life in the Canadian Registry of Palivizumab.

Methods: The Canadian Registry of Palivizumab is a prospective database of infants who received ≥1 dose of palivizumab in 32 hospitals from 2005 to 2015. Demographic data were collected at enrollment and RIH events recorded monthly. Infants <24 months of age with HSCHD were recruited.

Results: Of 1909 HSCHD infants, 1380 (72.3%) in the first year (mean age, 4.2 months) and 529 (27.7%) in the second year of life (mean age, 17.8 months) received prophylaxis. Baseline demographics for day-care attendance, multiple births, enrollment age and weight differed between the groups (all P < 0.05). Additionally, second year infants had a more complicated neonatal course, with significantly longer length of stay (51.2 vs. 24.9 days) compared with those in the first year. The RIH and RSVH rates in the first year were 11.2% and 2.3% and in the second year were 10.6% and 1.7%. Cox regression analysis showed similar hazard for RIH [hazard ratio, 1.9; 95% confidence interval: 0.7–4.6; P = 0.18] and RSVH [hazard ratio, 2.0; 95% confidence interval: 0.2–16.5; P = 0.52].

Conclusions: Infants in the first and second year of life had a similar RSVH hazard. These findings suggest that infants in the second year with HSCHD, who remain unstable, are equally at risk for RSVH and merit prophylaxis.

From the *Medical Outcomes and Research in Economics (MORE) Research Group, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, Ontario, Canada; Division of Respirology, Department of Pediatrics, University of Calgary, Calgary, Alberta, Canada; and Division of Neonatology, Department of Pediatrics, McMaster University, Hamilton, Ontario, Canada.

Accepted for publication September, 12, 2016.

The CARESS registry is funded by an investigator-initiated grant from AbbVie Canada. However, AbbVie had no role in the study design, data collection and analysis, decision to publish or preparation of the manuscript. Bosco Paes, Ian Mitchell and Krista Lanctôt have received research funding from AbbVie Corporation and compensation as advisors or lecturers from AbbVie Corporation and MedImmune. Abby Li has received speaker’s fees from AbbVie Canada. Daniel Wang has no conflicts to declare. The CARESS registry is registered under ClinicalTrials.gov Identifier (NCT00420966).

Address for correspondence: Bosco A. Paes, FRCPC, Department of Pediatrics, McMaster University, HSC-3A, 1280 Main Street West, Hamilton, Ontario L8S 4K1, Canada. E-mail: paes@mcmaster.ca.

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