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Does palivizumab prevent serious respiratory syncytial virus (RSV) infection in bronchopulmonary dysplasia (BPD) infants?

Three Part Question

In [BPD children discharged on home oxygen] does [prophylaxis with palivizumab] prevent [serious RSV infection]?

Clinical Scenario

A 24 week ex-preterm is going home on oxygen in the month of November. Parents have read about the risk of RSV infection and palivizumab prophylaxis. The drug company recommends palivizumab and parents would like their baby to have the prophylaxis. Is there evidence to support that palivizumab prevents serious RSV infection?

Search Strategy

Primary source: The Cochrane library (2004, Issue 1). Secondary sources: Medline 1966-2004, EMBASE 1974-2004, CINAHL 1982-2004 using the Dialog Datastar.
Primary source: The search term 'palivizumab'. Hits: 19, systematic reviews (2), controlled trials (8), economic evaluation (5) and health technology assessment (3)
Secondary search-The search term [{palivizumab OR synagis} OR {RSV AND monoclonal antibody} AND {BPD OR CLD}]. Filter meta-analyses and randomised controlled trials. Limit to human and english language. Hits Medline (1), EMBASE (8) and CINAHL (2)

Search Outcome

1 systematic review and 1 randomised controlled trial

Relevant Paper(s)

Author, date and country Patient group Study type (level of evidence) Outcomes Key results Study Weaknesses
Connor EM et al
1998
USA
1502 children with prematurity (Multicentre, randomized, double-blind, placebo-controlled trial (1b)Incidence of RSV hospitalization in BPD childrenTreatment:39/496 (7.9%), Control:34/266 (12.8%) (OR 0.57, 95% CI 0.34, 0.94) Calculated RRR 38%, ARR 5%, NNT 20Important outcome measures such as ICU admission, mechanical ventilation and mortality not included for the BPD group.

Comment(s)

RSV is the most common cause of lower respiratory tract infections in infants. The humanised monoclonal antibody (Palivizumab) has been developed for prevention of serious lower respiratory tract disease caused by RSV. Palivizumab prophylaxis therefore could be used in highly vulnerable BPD infants rather than all at risk preterm infants. The search retrieved a meta-analysis by Wang et al that analysed studies of immunoglobulins for preventing RSV infection. Critical appraisal of the review yielded the study by Connor et al that specifically addressed the use of palivizumab in preterm and BPD children. The data from the connors study was used to calculate relative risk reduction (RRR), absolute risk reduction (ARR) and number needed treat (NNT). The BPD group in the Connors study showed a 38% reduction in the rate of RSV hospitalisation but the ARR was only 5% with NNT of 20 which may not be cost effective. Also though important outcome measures such as ICU admission, mechanical ventilation and death were available for preterm cohort, similar data was not available for BPD group.

Clinical Bottom Line

Palivizimab prevents RSV hospitalisation in BPD children discharged during winter months (NNT 20). However there is no information on important outcomes such as ICU admission, mechanical ventilation and mortality to recommend its routine use in all BPD patients. Palivizimab may be considered for infants with BPD if the local rate of hospitalization attributable to confirmed RSV infection is frequent.

References

  1. The IMpact-RSV Study Group Palivizumab, a humanized respiratory syncytial virus monoclonal antibody, reduces hospitalization from respiratory syncytial virus infection in high-risk infants Pediatrics 1998,102 (3 Pt 1), P: 531-7
  2. Wang EEL, Tang NK Immunoglobulin for preventing respiratory syncytial virus infection (Cochrane Review) The Cochrane Library Issue 1, 2004