Respiratory syncytial virus prophylaxis in infants with congenital airway anomalies compared to standard indications and complex medical disorders
An observational study was conducted of children < 2 years who received ≥ 1 dose of palivizumab in 32 Canadian institutions from 2005 to 2017. We compared respiratory illness (RIH) and respiratory syncytial virus-related hospitalization (RSVH) hazards in children with a congenital airway anomaly (CAA) versus those prophylaxed for standard indications (SI) and serious medical disorders (SMD). Data were assembled on neonatal course, demographics, palivizumab utilization and adherence, and respiratory illness events, and analyzed using ANOVA, chi-square tests and Cox proportional hazards. Twenty-five thousand three children (1219 CAA, 3538 SMD, and 20,246 SI) were enrolled. Palivizumab adherence was 74.8% overall and similar across groups. For 2054 respiratory-related events, 1724 children were hospitalized. RIH rates were 13.6% (CAA), 9.6% (SMD), and 6.0% (SI). RSVH rates were 2.4% (CAA), 1.6% (SMD), and 1.5% (SI). After adjustment for demographic and neonatal differences, children with a CAA had a significantly increased RIH and RSVH hazard relative to SI (RIH, HR = 1.6, 95% CI 1.2–2.2, p = 0.002; RSVH, HR = 2.1, 95% CI 1.0–4.4, p = 0.037) but similar to SMD (RIH, HR = 1.3, 95% CI 0.9–1.9, p = 0.190; RSVH, HR = 1.7, 95% CI 0.7–4.1, p = 0.277).
What is Known:
• Children with congenital airway anomalies (CAA) are at risk for respiratory tract illness and respiratory syncytial virus-related hospitalization (RSVH) with accompanying morbidity and mortality
• RSV prophylaxis may be useful in children with a CAA, but is not routinely recommended
What is New:
• Children with a CAA had a 1.6–2.3 fold greater risk of respiratory-related hospitalization and RSVH compared to those prophylaxed for standard, approved indications and serious medical disorders.
• RSVH risk in children aged < 2 years with either upper or lower airway anomalies is similar. Children with a CAA require careful surveillance during the RSV season and prophylaxis may be appropriate.
KeywordsCongenital airway anomalies Respiratory syncytial virus Palivizumab Outcomes
Congenital airway anomalies
Respiratory illness hospitalization
Respiratory syncytial virus
Respiratory syncytial virus hospitalization
Serious medical disorders
The authors would like to thank the following investigators in the CARESS 2005-2015 seasons: Dr. Candice Bjornson and Dr. Ian Mitchell (Alberta Children’s Hospital), Dr. Mark Chilvers (BC Children’s Hospital), Dr. Georges Caouette (Centre Hospitalier de l’Université (CHU) Laval), Dr. Marc Lebel (CHU Sainte-Justine), Dr. Mario Eddy Dumas (CHU Sherbrooke), Dr. Charles Hui (Children’s Hospital of Eastern Ontario), Dr. Ann Bayliss (Credit Valley Hospital), Dr. Bruno DiGravio (Grand River Hospital), Dr. Jean-Pierre Doray (Hôpital Charles LeMoyne), Dr. Dora Stinson (IWK Health Centre), Dr. Apostolos Papageorgiou (Jewish General Hospital), Dr. Marianna Mitchell (Lakeridge Health Oshawa), Dr. David Lee and Dr. April Price (London Health Sciences Centre), Dr. Aaron Chiu (Manitoba Institute of Child Health), Dr. Bosco Paes (McMaster Children’s Hospital), Dr. Roderick Canning (Moncton Hospital), Dr. Anne-Marie Canakis and Dr. Jesse Papenburg (Montreal Children’s Hospital), Dr. Karel O’Brien (Mount Sinai Hospital), Dr. Karen Chang (Rouge Valley Hospital), Dr. Koravangattu Sankaran (Royal University Hospital), Dr. Vincent Ho (Royal Victoria Hospital), Dr. Larry Chang (Southlake Regional Health Centre), Dr. Cecil Ojah (St. John Regional Hospital), Dr. Sanja Avdic (St Joseph’s Health Centre), Dr. Upton Allen (Sick Kids Hospital), Dr. Carina Majaesic (Stollery Children’s Hospital), Dr. Marc Blayney (Sudbury Regional Hospital), Dr. Brian Simmons Sunnybrook Health Sciences Centre), Mr. Kiang Tang and Dr. Jelena Popovic (Toronto East General Hospital), Dr. Frank Jagdis (Victoria General Hospital), Dr. Ivor Margolis (William Osler Health Centre), and Dr. Godfrey Bacheyie (Windsor Regional Hospital).
Dr. Paes conceptualized the study, drafted the first version of the manuscript, and reviewed and edited the final version of the manuscript. Doyoung Kim, Mahwesh Saleem, and Sophie Wong were instrumental in the data assembly and analyses and the development of the tables and figures for submission. Dr. Ian Mitchell and Dr. Krista Lanctot critically reviewed the analyses and interpretation of the data and edited the final version for submission. All authors confirm responsibility for the reported research and have approved the manuscript as submitted.
The CARESS registry is funded by an investigator-initiated grant from AbbVie Corporation. The CARESS registry is registered under: ClinicalTrials.gov Identifier: NCT00420966.
Compliance with ethical standards
Conflict of interest
The Canadian RSV Evaluation Study of Palivizumab 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. Doyoung Kim, Mahwesh Saleem, and Sophie Wong declare they have no conflict of interest.
Investigators in all 32 Canadian sites where the Canadian RSV Evaluation Study of Palivizumab study was conducted received ethical approval from their respective institutional research boards.
All subjects were enrolled following full prior consent by parents or the legal guardian of the child.
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