scholarly journals RSV prophylaxis use in high-risk infants in Western Australia, 2002-2013: a record linkage cohort study

2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Ruomei Xu ◽  
Parveen Fathima ◽  
Tobias Strunk ◽  
Nicholas de Klerk ◽  
Thomas L. Snelling ◽  
...  

Abstract Background The monoclonal antibody, palivizumab is licensed for use in high-risk infants to prevent severe illness caused by respiratory syncytial virus (RSV). The level of its use and compliance with current jurisdictional guidelines which were amended in 2010, is unknown. We determined the level of palivizumab use in a cohort of high-risk infants in Western Australia. Methods Using probabilistically linked administrative data, we conducted a birth cohort study within tertiary neonatal intensive care units (NICUs) born between 2002 and 2013. We described palivizumab use by patient characteristics, eligibility criteria according to guidelines over the period of study and identified predictors of its use. Results Of 24,329 infants admitted to tertiary NICUs, 271 (1.1%) were dispensed 744 palivizumab doses with 62.5% being dispensed to infants born 2010–2013. The median number of doses received was 2. A total of 2679 infants met at least one of three criteria for palivizumab (criteria 1: gestational age at birth < 28 weeks and chronic lung disease; criteria 2: gestational age < 28 weeks and Aboriginal; criteria 3: congenital heart disease not otherwise in criteria 1 or 2). The extent of palivizumab use differed across the 3 groups. Of 803 infants meeting criteria 1, 21.8% received at least 1 dose of palivizumab; 52.8% from 2010 onwards. From 174 infants meeting criteria 2, 14.4% received at least 1 dose; 43.1% from 2010 onwards and from 1804 births meeting criteria 3, only 3.7% received at least 1 dose; 5.4% from year of birth 2010 onwards). In adjusted analyses, being born after 2010, being extreme preterm, chronic lung disease, congenital lung disease and being born in autumn or winter were independent predictors of palivizumab use. Conclusion In this high-risk setting and notwithstanding the limitations of our data sources, the level of compliance of palivizumab use against current guidelines was low. Most doses were dispensed to infants meeting at least one high-risk criterion. Evidence of incomplete dosing is an important finding in light of recent developments of single dose monoclonal antibodies offering longer protection.

2005 ◽  
Vol 15 (3) ◽  
pp. 256-265 ◽  
Author(s):  
Damien Bonnet ◽  
Achim A. Schmaltz ◽  
Timothy F. Feltes

The respiratory syncytial virus is the most common cause of infection of the lower respiratory tract in infants and young children, and is the leading cause of hospitalisation and death due to viral illness during the first year of life. In otherwise healthy infants, the virus usually causes only mild respiratory illness, but premature babies and infants with chronic lung disease, those with congenitally malformed hearts, or those who are immunodeficient, are at increased risk of serious illness, hospitalisation, and death. Recent infection with the virus is also associated with increased postoperative complications after corrective surgery for congenitally malformed hearts. No effective vaccine is currently available, and treatment is limited to supportive therapy. Prevention in groups deemed to be at high-risk, therefore, is essential. In addition to measures for control of infection, prophylactic immunotherapy is indicated in selected patients. Palivizumab (Synagis®) is a monoclonal antibody indicated for the prevention of serious viral disease of the lower respiratory tract in premature infants, those with chronic lung disease, and those with haemodynamically significant congenital cardiac lesions. Palivizumab is given intramuscularly, usually as a monthly injection during the so-called “season”. In a recent international, randomised, double-blind, placebo-controlled trial in 1,287 children less than or equal to 2 years old with haemodynamically significant congenital cardiac malformations, prophylaxis achieved a relative reduction of 45 per cent in the incidence of antigen-confirmed viral-related hospitalisation, and reduced the duration of hospital stay by 56 per cent. National and international guidelines, therefore, now recommend routine prophylaxis in the first year of life in children with haemodynamically significant congenital cardiac disease.


2014 ◽  
Vol 8 (1) ◽  
pp. 71-77 ◽  
Author(s):  
Bernhard Resch

Morbidity due to respiratory syncytial virus (RSV) disease is still high in infants and children worldwide during the first two to five years of life. Certain categories of high-risk infants with increased morbidity and mortality attributed to RSV disease have been identified and are included in national recommendations for prophylaxis with the monoclonal RSV antibody palivizumab. Most guidelines recommend palivizumab for preterm infants born less than or equal to 32 weeks gestational age with or without bronchopulmonary dysplasia, those born between 33 and 35 weeks gestational age with additional risk factors, and infants and children with hemodynamically significant congenital heart disease. Over the last years several rare diseases have been identified demonstrating high morbidity associated with RSV disease, thus, extension of guidelines for the prophylaxis with palivizumab for these patients with rare diseases including children with malignancy, congenital and acquired immune deficiency, Down syndrome, neuromuscular impairment, cystic fibrosis, congenital diaphragmatic hernia and other severe respiratory disease is increasingly discussed. Efficacy of palivizumab prophylaxis is documented by meta-analysis, and different economic analyses demonstrate cost-effectiveness of palivizumab for the most common indications during the first RSV season.


1999 ◽  
Vol 16 (2) ◽  
pp. 43-51 ◽  
Author(s):  
J.Anne Dezoete ◽  
Barton A. MacArthur

AbstractThis study identified selected perinatal and neonatal variables that place ELBW children at particularly high risk for cognitive delay. Forty children weighing less than 1000 grams (ELBW) at birth underwent developmentol assessment at 9 and 18 months on the Bayley II Mental Development lndex (MDI). Decline in MDI scores between these two ages was evident for infants under 26 weeks gestation at birth as well as for children categorised with an impairment (outcome categories I and II). At 9 months, MDI scores were significantly lower for children with chronic lung disease, for those who required formal developmental intervention, and for those hospitalised for respiratory problems. At 18 months, cognitive scores were significantly lower for children on four variables: gestational age less than 26 weeks; semi-skilled, unskilled, unemployed parents (levels 5 and 6); formal intervention; and admission to hospital for respiratory illness. Greater emphasis on intervention for these at-risk variables is recommended.


Author(s):  
Jesse Papenburg ◽  
Isabelle Defoy ◽  
Edith Massé ◽  
Georges Caouette ◽  
Marc H Lebel

Abstract Background Infants born at 33–35 completed weeks’ gestational age (wGA) aged &lt;6 months at the start of or born during respiratory syncytial virus (RSV) season and classified as moderate/high risk of severe RSV disease were included in a palivizumab RSV prophylaxis program in the province of Quebec, Canada, until 2014–2015. We assessed the impact of withdrawal of this indication on lower respiratory tract infection (LRTI)/RSV hospitalizations (H) in this population. Methods We conducted a 4-year, retrospective, cohort study in 25 Quebec hospitals (2 seasons with and 2 without palivizumab prophylaxis for moderate- to high-risk infants). Our primary outcome was LRTI/RSV-H incidence. We compared LRTI/RSV-H incidence before (2013–2015; seasons 1 + 2 [S1/2]) and after (2015–2017; S3/4) the change in indication. Results We identified 6457 33–35 wGA births. LRTI/RSV-H occurred in 105/3353 infants (3.13%) in S1/2 and 130/3104 (4.19%) in S3/4. Among LRTI/RSV-H, 86.4% were laboratory-confirmed RSV-H. Adjusting for sex, wGA, and birth month, S3/4 was significantly associated with increased LRTI/RSV-H incidence (adjusted odds ratio [aOR], 1.36; 95% confidence interval [CI], 1.04–1.76) but not with laboratory-confirmed RSV-H (aOR, 1.19; 95% CI, 0.90–1.58). Mean duration of LRTI/RSV-H was 5.6 days; 22.6% required intensive care unit admission. Comparing S3/4 with S1/2, infant percentage with LRTI/RSV-H classified as moderate/high risk increased from 27.8% to 41.9% (P = .11). Conclusions In a province-wide study, we observed a significant increase in LRTI/RSV-H incidence among infants born at 33–35 wGA in the 2 years after withdrawal of RSV prophylaxis.


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